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Marketing and the risks and benefits of HPV vaccine.

Merck's quadrivalent HPV recombinant vaccine, Gardasil, has been licensed for use in the US since June 2006. The marketing strategies used by Merck to promote the vaccine were based on its experience with hepatitis B vaccine, and aimed to avoid limiting the vaccine to high risk populations, such as those with high excess mortality from cervical cancer, instead, the vaccine was promoted for use in all women and as a safeguard against cancer, which minimised issues around the sexual transmission of HPV and maximised the threat of cervical cancer in later life for adolescents. Another strategy was to go through professional medical associations, which helped to secure government funding and mandates. The US Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, and American College Health Association helped market the drug by extensive use of educational materials such as ready-made presentations, slide sets, emails and letters, provided and funded by the manufacturer. According to these authors, much of the material did not address the full complexity surrounding the vaccine and did not provide balanced recommendations on risks and benefits. However, the strategy has been successful, with worldwide sales of Gardasil of US$1.4bn in 2008. (1)

During the first 2.5 years of the vaccine programme, there were 12,424 reports of possible adverse events after immunisation received by the US Vaccine Adverse Event Reporting System, a rate of 53.9 reports per 100,000 vaccine doses distributed. 772 of these (6.2%) were judged as serious adverse events, including 32 deaths. There were some reports of hypersensitivity reactions including anaphylaxis, Guillain-Barre syndrome, transverse myelitis and pancreatitis. Most of the adverse event rates were not greater than background rates when compared with other vaccines but there was disproportional reporting of syncope and venous thromboembolic events. The safety profile presented is broadly consistent with safety data from pre-licensing trials. However, because data from this voluntary reporting system cannot be used to infer causal associations between the vaccines and adverse events, ongoing monitoring will continue. (2)

When weighing evidence about risks and benefits, patients and the public expect that only medical and scientific evidence is considered, says an editorial. If other matters are included, such as profit for a company or financial or professional gain for doctors, or if adverse events are not calculated correctly, the balance is easily skewed. (3)

(1.) Rothman SM, Rothman DJ. Marketing HPV vaccine: Implications for adolescent health and medical professionalism. JAMA 2009;302(7):781-86.

(2.) Slade BA, Leidel L, Vellozzi C, et al. Post-licensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302(7):750-57.

(3.) Haug C. The risks and benefits of HPV vaccination. JAMA 2009;302(7):795-96.

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Title Annotation:ROUND UP: Service delivery; human papillomavirus
Publication:Reproductive Health Matters
Article Type:Author abstract
Geographic Code:1USA
Date:May 1, 2009
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