Women at the highest risk for human papillomavirus infection were among the least likely to get the message that there is a vaccine that can protect them, editorialists said in a special communication published in JAMA.
Sheila M. Rothman, Ph.D., and David J. Rothman, Ph.D., of Columbia University, New York, contend that Merck & Co. promoted its quadrivalent human papillomavirus vaccine Gardasil as an anticancer agent, maximizing the threat of cervical cancer and minimizing the sexual transmission of the virus.
“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,” Dr. Rothman and Dr. Rothman wrote (JAMA 2009;302:781–6).
Further, Merck's marketing strategy included awarding “sizeable educational grants” to professional medical associations in adolescent and women's health and oncology to encourage these organizations to undertake or intensify vaccination activities, according to the authors.
In an interview, Pamela Eisele, a spokeswoman for Merck, denied the claims. “We did not require any reporting or review of any materials developed,” Ms. Eisele said. “Merck provides independent grant support to professional medical associations that develop and distribute their own educational information about HPV and cervical cancer to broad audiences. Merck did not have any input or influence over the content of the materials those organizations developed.”
“We value our relationships with these groups and conduct our interactions with strict adherence to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals,” said Ms. Eisele. In addition, “Merck closely follows the standards for commercial support of continuing medical education established by the Accreditation Council for Continuing Medical Education.”
Dr. Rothman and Dr. Rothman charged that the role of several professional medical associations in the marketing of the HPV vaccine “is cause for concern.”
Professional medical associations “must become more transparent about their relationships with industry, disclosing both the precise funding and technical assistance they have received to develop and disseminate the promotional products.”
One recipient of Merck funding, the American Society for Colposcopy and Cervical Pathology (ASCCP), used the grant money to create a day-long program to educate its members on vaccine use. Further, the society developed a Gardasil-specific speaker support center that included a registry of members who completed the educational program and a database of when and where they presented, Dr. Rothman and Dr. Rothman said. The society also “arranged opportunities for CME-accredited courses” through various venues.
Attendees of the ASCCP educational program receive a Speaker Lecture Kit of nearly 200 slides with information on cervical cancer risk for medical and lay audiences as well as strategies for convincing government agencies to mandate HPV vaccination and for convincing insurers to pay for the vaccine, the editorialists noted. One of the slides recommended downplaying the fact that HPV is a sexually transmitted infection to minimize parental discomfort, according to Dr. Rothman and Dr. Rothman.
The ASCCP's member clinicians “have little occasion to recommend or deliver immunization,” and could potentially see a negative economic benefit from a successful vaccination effort, yet “ASCCP leaders perceived vaccine promotion as an opportunity to turn a potential financial liability into an asset,” and to re-energize its society, according to Dr. Rothman and Dr. Rothman.
“That is not the case,” Dr. L. Stewart Massad, chair of the ASCCP's Practice and Ethics committees, said in an interview. “We have long recognized that the current [cervical cancer] prevention system is flawed. Although prevention based on Pap testing, colposcopy, and destruction of precursors is effective, it is expensive, intrusive, insensitive, and nonspecific, and it results in the overtreatment of thousands of women each year.”
Given the potential for conflicts of interest associated with an industry-supported educational program, “we set up internal systems to evaluate the materials for bias, and I reviewed all of the materials independently,” Dr. Massad said, noting that he accepts no financial support or grant money.
Merck also gave grant money to the Society of Gynecologic Oncologists (SGO).
Dr. Rothman and Dr. Rothman wrote that the SGO was concerned about its future as a subspecialty and perceived the HPV marketing opportunity as a way to springboard its transformation from a surgically based to a medically based discipline. The organization used the funding from Merck and other companies to create a physician education campaign, which was overseen by a resource panel that included some members with financial ties to Merck.
The materials created by the SGO panel “omitted cautionary qualifications,” according to Dr. Rothman and Dr. Rothman. Further, the materials “did not include data on disparities in cervical cancer incidence and outcomes,” nor did it include questions about the vaccine's history and efficacy, whether the risks outweigh the benefits, or a discussion of the continued need for Pap tests.