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

Results

We interviewed 73 individuals in 51 solo and 9 group interviews. We interviewed at least 10 respondents in each state and 9 individuals who had been involved in multiple states or at the national level ( Table 2 ).

Merck's Role in HPV Vaccination Policymaking

Across all sampled states, the Merck role most consistently mentioned by interview respondents was serving as an informational resource to legislators and health department officials.

Providing Information. The company responded to specific requests for scientific information about Gardasil or potential policy strategies. Respondents did not perceive that this role jeopardized independent decision-making by policymakers. Officials at task force and advisory committee meetings that Merck representatives attended universally reported that the representatives contributed to the discussion only when asked. One health official noted, "It was definitely the policymakers who were ultimately making the decision."

Lobbying and Presenting Policy Alternatives to Legislators. Merck engaged in direct lobbying to varying degrees in all of the states we studied. Merck proactively contacted legislators to discuss strategies to maximize uptake of Gardasil, either directly through company employees or by using local political consultants, prominent physicians, or public relations firms.

Many respondents reported that company representatives proposed specific legislation, often drafting the bills and searching for a sponsor. In most states, their efforts focused on a school-entry mandate. Respondents pointed out that Merck's activities were not unusual, although the public seemed to have been unaware that private companies played such a role in the legislative process. One commented, "Just about every vaccine mandate that we have lately has been the result, at least partially, of the drug industry's efforts."

The intensity of Merck's lobbying efforts varied across states. No respondents in California recalled Merck representatives directly lobbying legislators. Direct lobbying reportedly took place in New Hampshire, but only briefly, and not aggressively: "It was gentle," a legislator recalled, "I suggested to them that [a school-entry requirement] probably wouldn't have a lot of traction here, and that was it. They dropped it." By contrast, in Indiana respondents consistently noted the high intensity of lobbying for school-entry mandate legislation. One respondent characterized it as a "feeding frenzy" designed "to convince us that this was the best thing since sliced bread."

Merck's lobbying raised special concerns in Texas. Shortly after Governor Perry issued an executive order in 2007 mandating HPV vaccination for girls, a public outcry was sparked by reports that the governor's former chief of staff had worked for years as a lobbyist for Merck (except during his employment in the governor's office) and that Merck had contributed $5000 to the governor's campaign fund.[6,7] In February 2007, Merck announced that it was suspending its efforts to lobby for state mandates.[8,9] Respondents remarked that Merck "backed away" after "it all hit the fan [and] Merck got beat up in the national press."

Ongoing lobbying efforts were more limited in scope and intensity, focusing on legislator education and funding for vaccines.[9] Respondents in New York and Texas opined that Merck's pullback—along with the Texas furor itself—undermined prospects for school-entry mandate legislation. By contrast, a governmental respondent in Virginia perceived that Merck's curtailment of its lobbying contributed to the passage of legislation. Lobbying had created the impression that "they were pushing this, when in fact we were following recommendations that our state wanted to do anyway."

Mobilizing Legislators, Stakeholders, and the Public. Merck mobilized legislators to introduce school-entry mandate and other legislation relating to the HPV vaccine, primarily through Women in Government (WIG), a national, nonprofit group of female state legislators. WIG had identified cervical cancer as a priority issue as early as 2003.[10] Merck contributed unrestricted educational grants to WIG, which, among other things, covered the expenses of dozens of legislators to attend conferences on cervical cancer at appealing destinations convened by WIG and attended by Merck representatives.[11]

In addition to hosting meetings at which legislators were briefed about HPV and Gardasil, WIG prepared reports on cervical cancer prevention efforts in the states, convened a task force to make policy recommendations, prepared a "legislative toolkit" containing model school-entry mandate legislation, and conducted outreach to interest groups and the media to build support for such legislation.[12,13] Members of WIG introduced many of the mandate bills considered across the country.[14]

Respondents were aware of the financial relationship between Merck and WIG. Some saw it as a natural affinity between 2 organizations with intersecting agendas, noting that Merck's grants to WIG were unrestricted and spending decisions were made by WIG's board. Others suspected that Merck had driven WIG's agenda rather than responding to it. One remarked, "WIG bit off hook, line, and sinker the need to have mandated this vaccination across America."

Respondents in every state commented on how effectively Merck prepared the political environment for the introduction of school-entry mandates and other legislation. The company carried out this objective through marketing campaigns to consumers and physicians and direct outreach to political interest groups.[6,15] Public health officials tended to view the direct-to-consumer advertising campaign positively because it motivated patients to seek out the vaccine. Legislators had mixed perceptions of how the media campaign affected legislative action. Several commented that it put the issue on the legislative agenda by creating a public demand for the vaccine, but one perceived that the campaign was so effective in stimulating demand that it had made legislation unnecessary.

There was less enthusiasm among respondents for Merck's marketing efforts to physicians. Merck conducted extensive outreach to the prescriber community, both directly and by training physicians to engage in peer-to-peer education.[6,16] A California governmental respondent related a historical analogy concerning Fosamax, Merck's drug for prevention of osteoporotic fractures:

They created this paranoia about fracture risk and applied it to a much bigger market. I think that they very successfully did the same thing with Gardasil…. They pumped up the level of fear among clinicians about the impact of HPV.

In addition to direct-to-physician marketing, Merck mobilized medical professional organizations and other interest groups.[16] Most respondents from medical and public health organizations described this outreach as fairly routine, although one indicated that the pressure was considerable: "At one point, the CDC rep for the state was being bombarded by pharmaceutical reps, so she asked if she could form an advisory committee around her." Merck also appears to have expanded its efforts to support interest groups financially. One organization that had long worked in the area of cancer prevention reported that both Merck and GlaxoSmithKline, the manufacturer of a competing HPV vaccine, came forward with unrestricted donations for the first time after Gardasil was introduced.

Filling gaps in access to the vaccine. One final role Merck played was helping to fill gaps in access to Gardasil by donating the vaccine. The company included Gardasil in the Merck Vaccine Patient Assistance Program, which ships vaccines to clinics and licensed prescribers for administration to low-income, uninsured adults. One New Yorker commented that Merck had

been very good about identifying the financial problems that exist…. We can't figure out how to [fill the gap for 19- to 26-year-olds], so they're trying.

Perceptions of Appropriate and Inappropriate Roles

We inquired as to what, if any, role respondents felt that pharmaceutical manufacturers should play in policy processes concerning vaccines. There was broad agreement that providing scientific information about products was vital to a robust policymaking process. This role seemed especially well received in states with "citizen legislatures," where part-time legislators had few resources for researching policy issues. Legislators and health officials acknowledged a risk that information provided by a vaccine manufacturer might be biased, but felt that "it's up to the legislators to sort that out," as one New Hampshire respondent put it.

Respondents also felt that it was appropriate for Merck to donate vaccine and for company representatives to sit in on task force or committee meetings, as long as they only responded to requests for information. Finally, among those who specifically discussed Merck's role in drafting legislation, no one opined that this was inappropriate.

Nearly all respondents thought that, in principle, a lobbying role for vaccine manufacturers was acceptable. A New York respondent noted that, in the past, collaborative efforts between legislators and pharmaceutical manufacturers had been "helpful in advancing access" to products such as Plan B. Many respondents saw Merck's business mission as consonant with a broader, public health mission:

The industry want[ed] to do a good thing and that was to get a good product out in the market that would help the most people. And, sure, there's a profit motive behind that, but they didn't see any inconsistencies between achieving both goals.

Merck's representative described the company's activities in terms of a partnership to ensure "optimal availability and optimal use of vaccines." He expressed disappointment that Merck's "motives were misinterpreted" and suggested that political interest groups had invoked Merck's financial interest as a red herring to defeat vaccination mandates they opposed on ideological grounds.

Although most respondents saw lobbying as appropriate, many felt that, in this case, Merck executed the role inappropriately. One concern, expressed by several health officials and representatives of groups of health experts, was that Merck's strategy involved an end run around health departments. Although in some states, most notably New Hampshire, there was extensive communication between Merck and the state immunization program, in others, respondents complained that Merck took its message directly to the public or legislature without involving public health officials. A Virginia respondent noted that Merck and other manufacturers had executed, but did not adhere to, an agreement with the Association of Immunization Managers to

inform the [health department] of their position and … seek to reach concurrence prior to undertaking activities in a state concerning legislation, regulation or other immunization policy change (e.g., vaccination requirements). [17] (p2)

She remarked, "Everybody signed off on it and then what happened, I don't know."

A second concern was that the company was too aggressive in pushing for a school-entry mandate so soon after the product's licensure. Moreover, many respondents thought that lobbying for Gardasil mandates presented a conflict of interest not as present in other lobbying efforts. A sizeable group of respondents that cut across states and stakeholder groups did not see Merck's financial mission and the mission of public health as consistent.

Some could not articulate a specific reason for taking this view, but it appeared connected to the fact that Merck focused on mandating immunization, which brought the coercive power of the state to bear on children and parents. Some respondents found it unseemly that Merck stood to profit from a "sweetheart deal" for a mandate or that legislators, in restricting individual liberty, would be influenced by a company with a financial interest in the legislation.

Respondents were divided in their views about whether it was appropriate for Merck to have provided financial support to WIG. One medical expert who had a relationship with Merck saw it as a sensible alliance: "I think it was an honest relationship. They latched onto Women in Government because they were interested in the cervical cancer issue." Some noted that Merck's support of WIG had been relatively restrained—for example, it had not provided large contributions to individual WIG members. Others found it "disconcerting" that "a company who is planning to make some money off a vaccine" would use WIG to try to mandate it.

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