Profit Knows No Borders, Selling Gardasil to the Rest of the World: Part Four of the Politics and PR of Cervical Cancer

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Canada

As in the United States, Merck's local subsidiary, Merck Frosst Canada, has lobbied aggressively for a government policy mandating blanket vaccination of young girls. Gardasil was approved in Canada in July 2006, and the first doses were given the following month. More recently, its National Advisory Committee on Immunization has recommended blanket vaccination for girls between the ages of nine and thirteen, with older girls and women also receiving "catch up" shots.

In February 2007, Ken Boessenkool, who served until 2004 as senior policy advisor to Canada's Conservative Prime Minister Stephen Harper, registered to lobby the federal government on immunization policy on behalf of Merck Frosst Canada. A month later, In March 2007, the Canadian federal government announced $300 million (US$288.4 million) in federal funding for a vaccination program to prevent cervical cancer, which would certainly benefit Merck Frosst, since currently it remains the only purveyor of the vaccine.

Not everyone in Canada is immediately jumping on the Gardasil bandwagon without hesitation. After my first article in this series appeared, I was contacted by Dr. Abby Lippman, a professor of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal and chair of the Canadian Women's Health Network/Le Réseau canadien pour la santé des femmes (CWHN). Her organization has prepared an extensive analysis of the current situation of the push for HPV vaccination in Canada. CWHN's recommendations include keeping the issue of HPV infection and its connection to cervical cancer within an overall perspective on women's reproductive and sexual health. Each year, about 400 women in Canada die of cervical cancer. CWHN points out that this number, while tragic, does not constitute an epidemic. Thanks to Merck Frosst's aggressive marketing of the drug, however, a general sense of panic about HPV has risen in Canada as it has in the United States. In June, CWHN prepared a policy paper titled "HPV, Vaccines, and Gender: Policy Considerations." It states that there are numerous reasons why mass vaccination of Canadian women and girls is premature and not advisable at present. They recommend other, more appropriate uses for the $300 million vaccine commitment by the Commonwealth government:

"... to fund a public education campaign to quell the unfounded anxiety that has been instilled by marketers of the vaccine that HPV represents a 'new' or 'imminent' threat; and to ensure equal access to Pap testing, including timely follow-up and application of improvements in testing. Only when there is a solid evidence base and an appropriately-provisioned cervical screening program accessible to all can we determine the most appropriate holistic strategy -- and the place of vaccination in it -- to address cervical cancer and the transmission of HPV between and among Canadian girls, boys, women, and men. We have been given an exciting opportunity to establish effective guidelines and to create a model of how to approach future vaccines. We must take full advantage of it."

CWHN insists that it is impossible to design an effective vaccination program without "clear and tangible" goals. "Is the aim of the vaccination program the eradication of high-risk HPV types from the population? Or is the aim to reduce the number of cervical cancer deaths?" they ask. "Different strategies are likely to be required to achieve these very different goals." Since Gardasil is only effective against two high-risk strains of HPV, they warn that there could be very serious and unintended consequences of mass vaccination. For example, it is not known and has not been studied whether the strains that are not covered by Gardasil would become more prevalent and stronger without "competition" from the two strains against which the current vaccine protects. This situation could lead to increased infection by strains against which there is currently no vaccine.

CWHN points to many of the concerns that I discussed in the first three articles of this series. They emphasize that the age group being targeted for mass immunization -- eleven- and twelve- year old girls -- was not the primary group studied when the drug was tested. In fact, only 1,200 nine- to fifteen-year olds were included in the study, and only 100 of them were nine-year olds, which is the age at which Canada's National Advisory Committee on Immunization (NACI) proposes to start vaccinating. Additionally, those nine-year olds were only followed for eighteen months -- hardly extensive efficacy research.


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