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.
CWHN also warns that aggressive marketing of Gardasil has muddied the waters in the media and in the mind of the public. "Media and marketing claims about the impact of HPV prevalence are very misleading and the naming of Gardasil as the 'cervical cancer vaccine,' implying the vaccine eliminates all cervical cancer, is incorrect. The marketing of Gardasil ... has made it difficult for there to be reflective discussions between parents and children, health care providers and their clients, as well as among the public and policy makers, about the nature and meaning of HPV and of vaccination."
AustraliaAustralia is in a unique position regarding the Gardasil vaccine because it was developed there by a well-regarded doctor, Ian Frazer, who was named Australian of the Year in 2006 specifically for his work on HPV. Key technology for the vaccine was discovered in 1991 by Frazer and Dr. Jian Zhou of China. They worked in collaboration with
CSL Biotherapies Limited, which then licensed the vaccine to Merck in 1995. Under the terms of their agreement, CSL retained the rights to market Gardasil in Australia and New Zealand, while Merck's territory covers the rest of the globe.
Australia is implementing nationwide vaccination against HPV, but on a voluntary opt-in, rather than opt-out, basis. Girls will bring a consent form home from school and parents will need to sign it for them to receive the three-shot vaccination at school. The Australian Government began providing Gardasil free to girls aged twelve and thirteen through the National HPV Vaccination Program in April 2007, and will continue on an ongoing basis. There will also be a two-year period where the vaccine will be provided free for girls and young women aged 14-26. The federal government will also cover young women who are not in school and are still under 27 years through their general practitioners and community immunization clinics. This age group will receive the vaccine free from July 2007, until the end of June 2009. According to the Australian Ministry of Health and Aging, the Commonwealth Government is providing $537 million (US$468.4 million) for the national HPV vaccination program. They also state that Australia has the second-lowest incidence of cervical cancer and the lowest mortality rate from cervical cancer in the world thanks to an excellent screening program, which will need to continue even with widespread vaccination.
Some of the confusion which has arisen due to the hype surrounding Gardasil was captured in an article published in the
Sydney Morning Herald. It quotes a 17-year-old girl who explaining that she decided to get vaccinated because two of her grandparents died of cancer. "It's a bit of a relief [that this vaccine is available] because it seems like we are actually getting somewhere in the fight against cancer," she says. Statistically, however, it is unlikely that her grandmothers died specifically from cervical cancer, and certainly her grandfathers did not. Hopefully she will be informed that Gardasil does not provide blanket protection against any cancers to which she may be genetically predisposed, or even against all forms of cervical cancer.
New ZealandIn New Zealand, about 180 women are diagnosed with cervical cancer every year, and around 60 die from the disease. CSL enjoys a long-standing relationship with the New Zealand government, having provided it with influenza, tetanus, and diphtheria vaccines for fourteen years. However, its push for HPV vaccination was dealt a blow in May of this year when Health Minister Peter Hodgson's office announced that the federal government would not be funding Gardasil in the current budget cycle. CSL Biotherapies (NZ) Limited immediately sought to meet with Prime Minister Helen Clark to ascertain if there was an alternate way for Gardasil to be funded in the 2008 budget. "It is hard to see how funding of Gardasil as early as possible could not be an imperative considering the lives that will be saved and improved," said Dave Bowler, General Manager of CSL (NZ). He added, "CSL Biotherapies would like to work with the Government to ensure that NZ girls and young women have access to a funded cervical cancer vaccine as soon as possible."
It is estimated that the cost to the New Zealand government would be $10 million (US$7.9 million) per year to vaccinate all girls in a single age group each year, not counting the cost of catch-up vaccination for those older than the recommended age at the start of the program. If vaccination is not approved for the 2008 vaccine roster, it will not be reconsidered for two years, by which time, Gardasil is likely to have lost its monopoly on the market. CSL has at least as much to gain by getting the vaccine added to the docket as New Zealand women might. To date, there has been no change in the NZ government's decision.
Just the Tip of the NeedleIn the
four articles of this series, we have examined the politics and PR of cervical cancer from several angles. The pre-FDA approval hype, masquerading as education, was executed by Merck and its partners, the
Edelman PR firm and non-profit organizations including the
Cancer Research and Prevention Foundation and
Step up Women's Network, to create a sense of fear and urgency in women and parents of girls. Merck continued using its successful non-profit partnership model to push for mandates of the HPV vaccine at the state level.
Women in Government, an industry-funded network of women state legislators proved a willing and able channel to influence policymakers across the country. All of this has happened against the backdrop of Merck's need to recoup financially and image-wise from the
Vioxx debacle that is still making its way through the courts, as well as its fleeting corner on the HPV vaccine market.
More could certainly be written about this issue, including an examination of
GlaxoSmithKline and its competing vaccine, Cervarix, that will most likely be FDA approved within a year and is showing more promising results than Gardasil. Legislation being introduced and voted on in various states should be tracked and assessed. And certainly, there is much more to be written about this women's health issue as it plays out around the world. Especially because the vast majority of cervical cancer deaths occur in the developing world, access to this very expensive vaccine will need to be pushed for and funded to be assured.
Since we began publishing this series, I have been interviewed personally by a variety of media outlets. Journalists have often been asked what I think of the vaccine after having researched it from several angles, particularly since I have a daughter of the age that is being targeted by the PR campaigns. My feelings about it are mixed. Because women's health is often the neglected stepchild of medicine, women are hungry for what sounds like a miracle development. Vaccination against HPV is probably the most exciting development in women's health in decades, but its worth has to be balanced with an understanding that it is not a "magic bullet" against cervical cancer. By overhyping its potential, Merck is contributing to a dangerous misconception and creating the risk of women will feel it is less important to have regular Pap screenings -- the tried and true, and very effective method for early detection and treatment of pre-cancerous conditions. It would be a tragic irony if women's infection and mortality rates from the disease actually
increase due to the belief that they are completely protected against cervical cancer.
I think that Merck's profit motive has led them to willingly allow and encourage exaggeration of the significant value of this vaccine with an overblown and harmful interpretation of it in the media and general public, fueled in large part by their four-part marketing campaign that primed the public for FDA approval of Gardasil. While the drug itself has beneficial potential, Merck's push for
mandated vaccinations primarily serve Merck, especially while it continues to have a corner on the market. At a minimum, mandated vaccinations should not be considered without more and better testing on eleven- and twelve-year old girls, and not until Cervarix or another competing vaccine is available. The role of corporate money in funding non-profit spokespeople that do their bidding in the guise of acting on behalf of the public should be exposed and discouraged, if not outright eliminated.
Women's lives will probably be saved by HPV vaccines now and in the future. For Merck, however, that may just be a pleasant side effect of their vaccine.
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