Drugs, sex, money and power: An HPV vaccine case study
Introduction
“It took 15 years for Gardasil to make a national hero of its creator, Ian Frazer. But it took just three days for the world's first cancer-preventing vaccine to make a national dill of federal Health Minister Tony Abbott. […] John Howard, alert as ever to the public mood, delivered sparkling prime ministerial endorsement to Gardasil along with a clear direction to Minister Abbott that the immunisation program should proceed. And pronto.” [1].
“[T]he public, as well as policy-makers, must be provided with sound and comprehensive multidisciplinary evidence for vaccination as well as unbiased data about the potential benefits and harms expected from widespread immunization with the HPV vaccine, and all this information must come before governments allocate huge sums of already limited health care dollars to such programs. Individual girls and women, as well as policy-makers, can only make truly informed decisions about vaccinations when they have all the evidence. At this point in time, there are more questions than answers.” [2, p. 16].
In this paper, we analyse and compare the experiences of seven countries (Australia, Canada, Denmark, Germany, New Zealand, Switzerland and the U.S.) in considering the world's first cervical cancer-preventing vaccine and making a decision about its introduction and/or funding. The above quotations nicely illustrate two characteristics of this process. First, on the whole, the countries considered here approved the HPV vaccine and related programs with marked haste, some circumventing established channels and procedures in the process. Second, public debates ensued in many countries, fuelled by uncertainties about the duration of the vaccine's efficacy and the precise nature of the link between HPV and cervical cancer. Because vaccine programs are still new, the rate of the HPV vaccine's uptake—and its impact on routine Pap test utilization—remains largely to be determined. With respect to the establishment of such programs, however, our analysis suggests that countries with different decision-making processes can arrive at a similar decision about the value of a health policy or program, a pattern that reflects the influence of a particularly strong and ubiquitous set of political pressures at work.
Section snippets
Materials and methods
The International Network Health Policy and Reform1
Human Papillomavirus and the development of a vaccine
Worldwide, cervical cancer is the second most common cancer among women [15]; nearly half a million women are diagnosed with and more than 270,000 die of the disease each year [16]. Of the more than 100 HPV strains that infect humans, more than 20 are linked to cervical cancer [17]. Cervical cancer is a rare outcome of a fairly common infection with HPV; in the majority of cases HPV infections are transient and asymptomatic [18], [19].
Nonetheless, the establishment of a viral cause of cervical
Comparing and contrasting the approval process
In all seven countries considered here, the vaccine was approved for use in 2006 and made available to women as a three-dose schedule for between 292 PPP-$ and 527 PPP-$2 (see also Table 1). Although there was debate in the scientific community about issues of safety and efficacy in connection with the approval process, the public debate, which is the subject
Role of the manufacturers
In countries with a pharmaceutical industry, manufacturers adopt practices designed to enhance the chances of their product being recommended, approved or subsidized. Such practices include employing lobbyists, engaging the media, and identifying potentially supportive groups within the community. In this case, the presence of the manufacturer was more obvious in some countries than in others, and its public profile varied. In Canada, Germany and the U.S., public perception that Merck, Sharp
Implementation and outcomes of the policy
In all countries except the U.S., HPV vaccination programs, whether delivered as a school-based program or via a health insurance package, are being offered on a voluntary basis. In the U.S., making vaccines mandatory for school enrolment is commonly accepted as a nearly foolproof means of achieving universal vaccination, but HPV vaccine mandates proved to be a failure in state legislatures across the country. More than a dozen states, however, approved related legislation, allotting funding to
Discussion
Although the scientific issues associated with the HPV vaccine are not unique, the case illustrates important issues associated with the interpretation of scientific knowledge for policy-making purposes. The overall objectives of a vaccination program are to reduce the morbidity and mortality associated with cervical cancer. However, the relationship between many HPV strains and morbidity and mortality is very complex and not well understood. Thus, there is, as yet, no direct scientific proof
Conclusion
The speedy introduction of a subsidized vaccination program across a number of developed countries represents a convergence of interests, whether motivated by profit or public health. Lessons about how to influence the public debate and maintain pressure on bureaucrats and politicians will not have been lost on advocates and lobbyists. Supporters of vaccination programs used the values of caring (for your daughter) and prevention (of cancer) to effectively argue for the vaccine's subsidy. Both
Acknowledgements
We are grateful to Revital Gross (Myers-JDC-Brookdale Institute, Jerusalem, Israel) and Gerard Anderson (Johns Hopkins Bloomberg School of Public Health) for their helpful feedback on the draft of this paper.
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