Pharmaceutical Companies' Role in State Vaccination Policymaking

The Case of Human Papillomavirus Vaccination

Michelle M. Mello, JD, PhD; Sara Abiola, JD, PhD; James Colgrove, PhD

Disclosures

Am J Public Health. 2012;102(5):893-898. 

In This Article

Discussion

Although it is ethically appealing to conceive of the policy process as insulated from the influence of private industry, the case of HPV immunization suggests that there is a symbiotic relationship between pharmaceutical manufacturers and state health policymakers. Companies depend on policymakers to stimulate demand for their products and provide for the financing and distribution of vaccines. State legislators, in turn, rely heavily on pharmaceutical companies for information, especially in states where legislators work part time with lean staff resources.

Legislators' own practices reinforced this dependence. It was striking that, in most states, even legislators who were leaders on health issues did not have close working relationships with their state's health department. Their failure to seek information from health department officials contributed to their dependence on industry. Many health department officials felt puzzled or disappointed that their ties to legislative health committees were not stronger, and some expressed concern that this lack of communication could lead to legislation that was logistically difficult to implement or scientifically unfounded.

The danger in relying on pharmaceutical companies to evaluate policy options is that they may not present information in the same fashion as a disinterested party, a possibility to which legislators in our sample were highly attuned. However, there was no indication from respondents that scientific information provided by Merck was inaccurate or biased. Nevertheless, it emerged strongly from our interviews that the terms of the debate were set very early on by Merck's effective communication of its position favoring school-entry mandates. Information gathering from a broader range of sources, including public health experts, might have led to a different policy agenda.

Legislators in our sample acknowledged the utility of the legislator educational programs that Merck underwrote through contributions to WIG. However, respondents also saw political hazards associated with providing such contributions. "I suspect that if they hadn't been quite as involved financially it actually may have played out in their favor a little better," one California respondent observed.

Many respondents were aware that the business practices of pharmaceutical manufacturers were of great public concern at the time legislators took up the issue of school-entry mandates for Gardasil. The legislative debates came on the heels of the Vioxx and Celebrex controversies[18] and several large pharmaceutical fraud settlements. This charged political environment has not abated, so industry-supported legislator education may encounter the same public consternation going forward. The use of intermediary organizations like WIG to sponsor educational programming may do little to dissipate concern.

The concern respondents expressed over financial entanglements between Merck and legislators was centrally a concern about transparency—one that has also been voiced about Merck's relationship with physician professional organizations.[16] Policymakers tended to be most disturbed by Merck's nontransparent roles, such as giving financial contributions to WIG and other interest groups that were not publicly disclosed. Such tactics "gave credence to people's fears that they were trying to do things behind closed doors and push things down people's throats," a Virginia respondent commented.

The number of governmental and nongovernmental respondents who thought it was appropriate for Merck to be involved in the policy deliberations as long as its role was transparent contrasts strikingly with views held by public health experts and the public.[19,20] For example, commentators have urged that

Since the manufacturer stands to profit from widespread vaccine administration, it is inappropriate for the company to finance efforts to persuade states and public officials to make HPV vaccinations mandatory. [20] (p1922)

Our respondents were more pragmatic, noting beneficial aspects of the company's involvement and denying that there was any conflict between Merck's economic interests and the public health mission.

The question of whether a conflict of interest existed for Merck is an interesting one. Conflicts of interest are defined as

a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. [21] (p46)

The primary interest of a pharmaceutical company is developing and selling pharmaceutical products. Because Merck's pursuit of its primary interest was not compromised by a secondary interest, "conflict of interest" is the wrong frame for what respondents found troubling about Merck's role (though it captures their concerns about policymakers who accepted contributions from Merck).

Rather, respondents' concern was that an organization whose primary interest was not promotion of the public good might influence policymakers to adopt a law that people found intrusive. Vaccination mandates involve a bodily invasion. There were also worries that a Gardasil mandate would financially burden families and necessitate a conversation about sexuality that many parents were not ready to have with their preteen daughters.[22] What seemed to weigh heavily on respondents' minds is that legislators should impose such burdens only after very careful consideration of what was in the public interest—not Merck's interest.

Lastly, the Gardasil story shows that vaccine manufacturers' political strategies need to be carefully calibrated to the political climate and may backfire if too aggressive. Some respondents felt Merck had underestimated the degree to which conservative groups and the public in some states would object to the idea of a mandate for a sexually transmitted infection. Compounding the political challenge were concerns about Gardasil's safety profile[11] and suspicions that Merck was motivated by a desire to position its product in the market before GlaxoSmithKline's rival vaccine won Food and Drug Administration approval.[23] Some legislators perceived that mandate legislation would have had greater success had the company waited a year or more. As it was, a representative of a national group remarked, it was "a case study of how not to get something passed."

Our methodology had limitations. We reported individuals' perceptions of the policy process, which may be contested. The states we selected for study cannot be considered representative of all states and the number of respondents interviewed in each state was relatively small. However, each state's respondent sample includes the full range of stakeholder groups identified in our recruitment plan.

In conclusion, the case of HPV illustrates the complexities of immunization policymaking in the states. Our nonrandom sample of 6 states is not necessarily representative of all 50 states and their experiences, but does illuminate key lessons emerging from hotbeds of policy activity. Although policymakers acknowledge the utility of vaccine manufacturers' involvement, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines. In the future, more restrained industry outreach that is focused on providing scientific and technical information about the vaccine may improve the outlook for legislation that is seen as legitimate by the public it both burdens and benefits.[24]

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