That’s what Margaret McGlynn, who heads the drugmaker’s vaccine business, tells The Star-Ledger of New Jersey in an interview. She insists the controversial effort to require adolescent girls to receive the HPV vaccine, which is designed to thwart cervical cancer, was the doing of Women In Government, an ad-hoc collection of state legislators. However, McGlynn acknowledges funding the group and was aware of its interest in cervical cancer. Just to be clear, earlier this year, Richard Haupt, Merck’s director of medical affairs, said the drugmaker has “decided at this point not to lobby for school laws any further,” and admitted the controversy was a distraction.

SL: The strategy of getting states to mandate Gardasil for school girls got swept up in controversy and, ultimately, fizzled out. What happened?

McGlynn: That actually wasn’t a strategy. School requirements are in place because, historically, states have realized that it’s very hard to achieve high immunization rates, especially in the lower socio-economic classes. It was also influenced by diseases that were communicable in the classroom setting. School requirements have emerged over time as a very important public health tool. It’s the state legislators who make those decisions.

So what happened with (Gardasil), the Women in Government group that came together many years ago to pursue issues that were important to them as females, they had adopted cervical cancer in totality and have screening programs and other things in place. Most states passed a law to set up a cervical cancer task force to determine the right approach to screening, education and vaccines when one became available. All of this took place outside of Merck.

Certainly, Women in Government approached us as they approach any company that’s involved in the causes they’ve taken on. They’re looking for funding support…

…They want to provide educational materials to their constituents. As Gardasil started to be broadly used, the cervical cancer task forces had to decide what the right approach was for their state. Different states took different approaches…The governor of Texas decided to issue an executive order. Many groups were very upset about that and felt a debate within a legislative setting was the route that should have been taken. That wasn’t Merck, but certainly fingers were pointed at Merck.

What’s happened in the past several months, there are a few states that have passed laws with school requirements. All of the laws, by the way, have an opt-out provision. If a parent feels they’re not supportive of immunization or they would prefer to wait a few years longer, they have that option.

This is the rest of the interview… (Full disclosure: The Star-Ledger of New Jersey owns Pharmalot).

SL: What triggered the resurgence of vaccine development?

McGlynn: I think what happened was we achieved significant progress in the ’60s, ’70s, ’80s, but then it stopped. I think the entire 20th century will end up being considered the age of vaccination. Think about all the diseases at the beginning of the century that we had millions dying from around the world that were virtually gone or well-managed by the end of the century. Measles, mumps, rubella, polio, hepatitis B, all of those diseases had vaccines available.

What happened as you got into the late ’80s and the ’90s, the tried-and-true approach to vaccine development - where you took the pathogen and you attenuated the pathogen and killed the pathogen and introduced it into a human being with a goal of eliciting an antibody response - the diseases for which that worked, we had essentially conquered. Companies were then looking at having to totally revolutionize their approach to vaccine development.

At the same time, they recognized the investment in vaccine development was getting higher and higher, especially as you needed to invest in these revolutionary approaches. The risk was much higher because the easier targets had been addressed through the tried-and-true approach. The other very important factor is that the prices that existed in the marketplace did not reflect the true value of the vaccines. When you looked at the opportunities for investing your research dollars, vaccines did not present anywhere near the compelling opportunity that pharmaceuticals did. Many companies exited the business.

You had four or five major companies that stayed invested in vaccines. What happened at these companies, especially Merck, was that we stayed committed to research. We invested in new approaches such as virus-like particles that resulted in our (Gardasil) vaccine. We focused on diseases where there was a very high unmet medical need and where we believed the value we could deliver with a very compelling vaccine would be recognized by payers.

SL: How is marketing vaccines different than marketing other pharmaceutical products?

McGlynn: What’s absolutely critical with vaccines is to establish the policy support and the funding support. In most of the categories in which we compete, it’s really soliciting brand preference for your product versus an alternative product. A lot of your marketing and selling effort is around messaging about the specific clinical and patient benefits of your particular product.

When you introduce a new vaccine, your focus is on establishing the benefits of immunization as a paradigm and a policy for that particular disease area. In the US, we’re fortunate to have the vaccines for children program, which provides funding for low-income age 18 and under. In other countries, tremendous efforts are required to solicit funding for (specific age categories)…So that’s a major difference, the importance of the policy recommendations and the funding.

SL: Zostavax is another important vaccine, which protects against shingles. How is it doing?

McGlynn: I think you’ll see acceleration over time. What’s very important with shingles is to educate both physicians and patients that there’s now a solution. There are a few barriers that we’re working to overcome. One is the initial formulation of the vaccine is frozen, and not all physicians have freezer capacity in their offices. Within the next few years, we expect to have a refrigerated formulation on the market.

SL: What can you tell us about Merck’s vaccine pipeline?

McGlynn: Staphylococcus aureus is a common problem that occurs when patients are hospitalized. We are studying a vaccine or a target that will prove to be a vaccine to prevent it. As we go further into stages of research, we’ll talk more about it.

SL: Is it possible we’ll see more vaccines in the future that will protect against other forms of cancer?

McGlynn: We’re doing research. It’s hard to say. There may be other cancers that are caused by infections. Or it may be - what’s more likely, I believe - in cancer there can be more stimulating the body’s own immune system through a vaccine.