A commentary in the current issue of the journal JAMA [abstract only] addresses Merck’s marketing of its HPV vaccine, Gardasil, and describes several ethical and public health-related problems with the company’s approach.
The authors observe that the vaccine was “promoted primarily to ‘guard’ not against HPV viruses or sexually transmitted diseases but against cervical cancer,” and provides an interesting critique of the broad approach vaccine-maker Merck used. The company’s tactic was to encourage all girls within a certain age group to be vaccinated as a cancer avoidance measure, rather than to work with public health officials to target those girls at the highest risk:
Marketing this HPV vaccine as an anticancer vaccine appears to have enabled its manufacturer to circumvent possible parental and public unease with an antidote to sexually transmitted diseases. But in doing so, the company bypassed public health officials who would have spearheaded a risk-sensitive vaccination campaign. So too, this manufacturer understandably wanted as many adolescents as possible to be vaccinated. But the pursuit of this goal was neither cost-effective nor equitable. It meant rather than concentrating on populations in geographic areas with excess cervical cancer mortality, including African Americans in the South, Latinos along the Texas-Mexico border, and whites in Appalachia, the marketing campaign posited that every girl was at equal risk: “Your daughter could become 1 less life affected by cervical cancer.”
The authors also explain how, in order to “avoid limiting the vaccine to high-risk populations, promote it for all women, and secure government reimbursement and mandates,” Merck approached professional medical associations (PMAs), and funded them to promote the vaccine. These included the American College of Obstetricians and Gynecologists, American Society for Colposcopy and Cervical Pathology, the Society of Gynecologic Oncologists , and the American College Health Association, according to the authors.
Funding to at least one of these organizations was used to develop a kit to guide speakers in promoting the vaccine, including the directive to encourage the audience to ask for state mandates and funding for the vaccine. Speakers were also instructed to play down sexual transmission of HPV, and the organizations were asked to report back to Merck on their promotional talks.
The authors of the commentary describe the ethical problem with this approach, and provide guidance to medical organizations:
Professional medical associations are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients. To this end, PMAs must become read transparent about their relationships with industry, disclosing both the precise funding and technical assistance they have received to develop and disseminate the promotional products. Under no circumstances should PMAs administer product-specific speakers’ bureaus, nor should they accept funding that requires them to report activity to the donor.
A related editorial on the risks and benefits of HPV vaccination is freely available in the same issue of JAMA. In it, the author explains that while “the theory behind the vaccine is sound,” long-term follow-up is needed to determine whether there is an effect on cervical cancer incidence 20-40 years from now. The author also notes that the net benefit of the vaccine to an individual woman is currently unknown.