Political Pitfalls in Policymaking: The Texas HPV Vaccine Policy Saga

In late 2005, while completing a post–doctoral fellowship at Baylor College of Medicine studying cancer disparities, I was asked to participate in a large–scale state health policy task-force on cervical cancer, a disease whose burden is felt disproportionately by certain minorities and socioeconomic groups. Back then we were poised to have the unprecedented opportunity to dramatically reduce the incidence of cervical cancer due to the imminent approval and release of vaccines to immunize young girls from certain strains of the Human Papilloma Virus (HPV)–the sexually–transmitted pathogen responsible for most cases of cervical cancer.

As a member of the Cervical Cancer Strategic Planning Initiative’s (CCSPI) Policy Work Group, I attended policymaking conferences convened in Austin, which were funded and organized by various agencies and organizations like the Texas Department of State Health Services and the Texas Cancer Council. But even more prominent and insistent in our policy taskforce meetings than the perpetually understaffed state agencies was the charismatic and influential presence of Women in Government (WIG), a large non–profit advocacy organization that includes many of the nation’s female legislators (including several close to then Texas governor Rick Perry). In fact, it had been at WIG’s behest, at its Cervical Cancer Summit in 2005, that Texas was singled out as the proving grounds for a push to enact liberal HPV vaccination policies into state law. And so it was that a large group of disparate stakeholders, health care professionals, grassroots activists, academics, cancer survivors, health economists and health policy wonks were all convened in Austin to prepare comprehensive policy recommendations on what Texas could and should be done once Merck’s Gardasil–projected to be the first FDA–approved HPV vaccine–became available in a few months.

Beginning at the end of 2005, the taskforce worked to deliver thoughtful policy recommendations we would deliver to Rick Perry’s office. These sessions were well–financed, well–support staffed and filled with people from all over Texas with plenty of expertise, but since the actual vaccines were still in development at Merck and GlaxoS-mithKline (GSK), and little was publicly known about their relative safety and efficacy, we required access to unpublished data from the ongoing vaccine trials in order to base our recommendations on the best science available. This, it turned out, was not as difficult as it may sound. Although in private drug development the data generated by trials is usually a closely guarded trade secret until disclosure is required for patenting or for FDA approval, Merck didn’t wait for us to ask. Several Merck representatives were among the attendees at every CCSPI meeting. At first, I assumed that due to the pharmaceutical company’s obviously important role as the sole possessor of necessary information for our deliberation, Merck was asked to attend from the start. It wasn’t until later that I found out that Merck was in fact the prime mover behind this policymaking process, and their influence had begun well before the WIG summit in 2005. And although Merck’s obvious conflict of interest (the company stood to make many millions if not billions from any aggressive state vaccination policies) caused us to restrict Merck’s involvement to being a source of vaccine information when we asked for it, the pharmaceutical giant remained a constant presence throughout our policymaking.

The Policymaking Process

Although the morbidity and mortality associated with cervical cancer is not trifling, the policy work group decided early on not to recommend for mandatory vaccination of age–appropriate girls in Texas (the only group for which the new vaccine was expected to receive initial FDA approval). This decision was based on a variety of factors including the lack of long–term safety and efficacy data for the vaccine at the time, and the widespread belief among the policy taskforce members that a vaccine mandate bill would have little chance of passing the conservative legislature of Texas, a state that had seen very vocal criticism of the vaccine ever since it had been announced. Instead, we opted for a policy recommendation that showed...