New York Times Examines Development, Advertising Of HPV Vaccines

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 21 Aug 2008 - 6:00 PDT

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In the last two years, cervical cancer has gone from an "obscure killer confined mostly to developing countries" to the "West's disease of the moment" through the "lightning-fast" transition of new human papillomavirus vaccines from development to "must-have injection[s]" in the U.S. and Europe, the New York Times reports. Cervical cancer is the second leading cause of cancer-related deaths among women worldwide, with 500,000 new cases diagnosed annually. According to the World Health Organization, about 95% of the 274,000 women who died of cervical cancer in 2006 lived in developing countries (Rosenthal, New York Times, 8/20).

Two HPV vaccines, Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix, in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. Gardasil also has been shown to be about 99% effective in preventing HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 6/20). Gardasil has been approved by FDA and many other health agencies in countries worldwide, while Cervarix has been approved in Europe and other countries and is pending U.S. approval. The federal government covers Gardasil vaccinations for some low-income girls up to age 18 at a cost of more than $1 billion, and measures to require middle school girls to receive the vaccine have been proposed in 24 states, the Times reports. Virginia is the only state to pass a mandate, and it will go into effect this fall. The United Kingdom's National Health Service also recently announced it will begin covering Cervarix vaccinations for 12-year-old girls in September.

According to the Times, the quick roll out of the vaccines "represents a triumph" of what the drug companies call "education and their critics call marketing." Merck has released several award-winning advertising campaigns for the vaccine, has paid hundreds of physicians $4,500 each to give 50-minute multimedia presentations about Gardasil, and has funded numerous organizations for cervical cancer awareness conferences and campaigns, the Times reports. In addition, Merck initially advocated state mandates for middle school girls to be vaccinated before halting direct lobbying last year, and the company has provided the American College Health Association an unrestricted grant to train officials to speak about the vaccine and cervical cancer to college health services. Although "[a]ggressive pharmaceutical advertising is nothing new," the campaigns are a "revolution" for vaccines, which traditionally have been "cheap and not particularly profitable." Gardasil costs about $360 for the three-dose series, and the total cost can range from about $400 to nearly $1,000, including office visits. The total cost often is partially covered by insurance, the Times reports.

Although some critics have said the advertising efforts have caused HPV vaccines to be rolled out too quickly in wealthy countries, "[e]ven critics of the marketing efforts recognize the benefits of the vaccines," the Times reports. Jon Abramson, a professor of pediatrics at Wake Forest University and chair of a CDC advisory committee that recommended Gardasil vaccination for all 11- and 12-year-old girls, said he was surprised that states were considering mandating the vaccine for enrollment in school but added, "Cervical cancer is a worthwhile disease to prevent in a country that has the resources." Abramson said the vaccines should be available to people who want to receive them. Some health economists have estimated that depending on how the vaccines are used, they might cost between $30,000 and $70,000 for each year of life saved in developed countries. However, if the vaccines were to become cheaper in developing countries, especially in Africa, it would "revolutionize women's health," the Times reports. Some not-for-profit groups, such as the Global Alliance for Vaccine and Immunizations, are attempting to find ways to make the vaccine less expensive in developing countries.

According to the Times, there also are some unanswered questions about the vaccines, including how long immunity to the HPV strains will last and concerns about side effects. Gardasil has been studied in clinical trials for five years and Cervarix has been studied for more than six years. Diane Harper -- a professor of medicine at Dartmouth Medical School, and a principal investigator of clinical trials of both Gardasil and Cervarix -- suggested that a longer approval process -- typically three years followed by a five to ten year period for a product to gain more universal acceptance -- allows you to "learn a lot about safety and side effects and how to use it." Harper said that in the Merck vaccine trials, Gardasil was no longer protective after just three years in some girls and believes that at least one booster shot, and probably more, would be needed over a lifetime. Merck Medical Director Richard Haupt said that the "durability of immunity" of Gardasil will be defined through widespread use of the vaccine but added that the company's research has indicated that immunity will last far more than five years. There have been 9,749 reports of potential adverse impacts of Gardasil to CDC, about 94% of which were not serious. FDA and CDC in a joint report released last year said that "Gardasil continues to be safe and effective and its benefits continue to outweigh its risks" (New York Times, 8/20).

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