Maureen Lafrenière

Last year's federal budget commitment of $300 million to vaccinate girls and women against human papillomavirus (HPV) received a mixed reaction from consumers, health professionals and the media.

Although preceded by Health Canada approval in 2006 and a positive recommendation from the National Advisory Committee on Immunization, the March 2007 budget announcement took many by surprise, since the Canadian Immuniza-tion Committee, vested with the responsibility to determine that vaccines are effective and cost-efficient, had neither completed its study of potential benefits nor issued recommendations on public funding for the vaccine.(1)

Acclaim for Gardasil®, a ground-breaking product with potential to prevent some cancers and the only HPV vaccine approved for use in Canada, has been mitigated by questions about long-term safety, efficacy, cost and need. Fuelling uncertainties are reports of a comprehensive advertising and lobbying campaign by manufacturer Merck & Co., Inc.(2) – characterized by many as aggressive – with the goal of mandatory school-based vaccination programs.

How did Gardasil, a vaccination program costing $404 for a three-dose treatment, succeed in attracting so much attention and so many public health dollars so rapidly? According to the Globe & Mail, "… aside from polio [vaccine in the 50s], no vaccine has gone from regulatory approval to mass use in government-funded programs with such dizzying speed."(3) (Varivax®, the chicken pox vaccine, also from Merck, cost $75 per shot, and received public funding six years after Health Canada approval.(4)

With the help of PR giant Edelman, Merck's awareness and advertising campaign in the U.S. started well before the vaccine's 2006 approval by the Food & Drug Administration.

Using celebrities and not-for-profit organizations, the 2005 "Make the Connection" campaign, focusing on the HPV virus/cervical cancer link, used the internet, television, print and orchestrated public events to reach an estimated 563 million people.(5) This was followed by "Make the Commitment" which challenged women to sign an online pledge to "talk with my healthcare professional […] about ways that I can prevent cervical cancer, including getting regular cervical cancer screenings."

Prior to FDA approval, the name Gardasil could not be used in advertising; nonetheless, promotion escalated with "Tell Someone", a series of television and internet ads featuring women who promise to tell someone they love about the high prevalence of the HPV virus and its connection to cervical cancer. (In Canada, rules governing direct-to-consumer advertising of pharmaceutical products prevented the "Tell Someone" website from naming the company.)

Within months of the vaccine's FDA approval in the U.S., a series of television, print and online ads appeared using the slogan "One Less" [e.g., "I want to be/want my daughter to be one less woman to battle cervical cancer"]. A recent campaign – "I chose" [to be vaccinated] features a 60-second ad that ran in U.S. and Canadian theatres during the recent run of the film 'Sex and the City'.(6)

The efforts of Merck and its advertising agencies have not gone unnoticed. Numerous awards and honours recognize the scope, ingenuity and effectiveness of the Gardasil campaigns in North America and elsewhere. Merck was honoured at the PhAME (Pharmaceutical Marketing and Advertising Excellence) Awards in 2008 with Best Branded Print Ad, Best Branded TV, Best Integrated Campaign, Best Multicultural Campaign and Marketer of the Year. The awards "recognize creative excellence, results that contribute to the public health, and innovation in strategies, media and integrated campaigns"(7).

The push for legislation
In tandem with promotion to the general public was a meticulous U.S. campaign advocating school-based vaccination programs at state level. Merck supported Women In Government (WIG), a not-for-profit network of women state legislators, whose members proposed legislation providing public funding for school-based vaccination programs.(8) However, after the Texas legislature overruled an executive order by the Governor mandating vaccination of all Grade 7 girls, Merck announced that it would no longer lobby at state level.(9)

Lobbying in Canada
In Canada, the PR firm Hill & Knowlton, working for Merck Frosst Canada Ltd., employs a former senior policy advisor and campaign consultant to Stephen Harper. This man registered as a federal government lobbyist on immunization policy just a month before the $300 million was announced as part of the 2007 budget.(10) The president of Hill & Knowlton Canada, another influential political adviser and campaign strategist to the Prime Minister, was also retained by Merck to lobby on immunization.(11)

Then, shortly before the Ontario Government's announcement of a vaccination program for Grade 8 girls in August 2007, two more employees of Hill & Knowlton registered as provincial lobbyists on immunization. One had formerly been employed by Premier McGuinty's office; the other is former chief of staff to the Ontario Health Minister.(12)

The bottom line
For Merck shareholders, approval, public acceptance, and distribution of the vaccine is not insignificant. According to the Wall Street Journal, "Mandatory vaccination across the U.S. would make Gardasil an automatic blockbuster for Merck at a time when the patents on some of its best-selling drugs are expiring and it's desperate to replace their revenue streams."(13)

After the loss of patent protection for the cholesterol drug Zocor® in 2006, the expiry of the osteoporosis medication Fosamax® this year will have a profound impact. The company's projected sales revenues for 2008 are expected to be half of last year's.(14) Compounding the situation is the 2004 voluntary withdrawal of Merck's top-selling arthritis drug, Vioxx® (with $2.1 billion in annual sales) after a public health advisory from the FDA. Merck recently settled the first of several class-action suits with former Vioxx users for $4.5 billion.

On the other hand, worldwide sales for Gardasil® in 2007 totalled $1.5 billion and some financial analysts predict sales will reach $2.6 billion to $3.8 billion by 2012. Two other population groups – women between the ages of 27 and 45, and boys – are being evaluated as potential candidates for the vaccine, although the FDA recently turned down Merck's application covering vaccination for the first group.(15)

Notes:

1. Picard, A.: 'How politics pushed the HPV vaccine.' The Globe & Mail, August 11, 2007 [www.globeandmail.com]. The CIC is a "federal-provincial-territorial body whose role is to determine that vaccines that are effective and cost-efficient are made available equitably to all Canadians."
2. The Canadian subsidiary is Merck Frosst Canada Ltd.
3. see 1
4. Talaga, T.: 'Lobbyists boosted vaccine program,' Toronto Star, August 16, 2007 [www.thestar.com].
5. Siers-Poisson, J.: 'The politics and PR of cervical cancer'- a series of 4 articles [www.prwatch.org]
6. Hylton-Austin, H.: 'Selling Gardasil at the movies,' Time Magazine, June 19, 2008 [time.com]
7. [www.rxawards.com]
8. see 5
9. Saul, S. & Pollack, A: 'Merck to halt lobbying on vaccine for girls.' New York Times, February 21, 2007 [www.nytimes.com]
10. Hill & Knowlton press release, Sept. 5, 2007 [www.hillandknowlton.ca/index.php/ news/press_releases/8html]
11. Ivey National Conference on Crisis Leadership, April 2006 [www.iveybuilds. com/content/more/news_0004.htm]
12. see 4
13. Carreyrou, J.: 'Moves to vaccinate girls for cervical cancer draw fire,' Wall Street Journal, February 7, 2007
14. Smith, A: 'Merck's other big problem.' January 30, 2006 [www.cnn.money.com]
15. Hoffman, J.: 'Vaccinating boys for girls' sake?' Int. Herald Tribune, February 28, 2008 [www.iht.com]
16. Krauskopf, L.: 'Merck's Gardasil not cleared for older women,' Reuters, June 25, 2008 [www.canada.com]

Other sources:
Zimm, A. & Blum, J.: 'Merck promotes cervical cancer shot by publicizing viral cause,' www.Bloomberg.com, May 26, 2006

S. Saul & A. Pollack: 'Furor on rush to require cervical cancer vaccine.' New York Times, February 17, 2007 [www.nytimes.com]

S. Page: 'Everything you wanted to know, but were afraid to ask.' Ottawa Citizen, April 29, 2007 [www.canada.com]

Canadian Women's Health Network: 'THE HPV vaccine, one year later' CWHN Magazine, Spring/Summer 2008 [www.cwhn.ca]

Prevent Cancer Foundation [www.preventcancer.org].

Also [www.cbcnews.ca], [www.tellsomeone.ca] and [www.oneless.ca]

My thanks to Dr. Peter Weldon for advice and help in researching this article. M.L.