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http://www.prwatch.org/node/6263

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

Submitted by Judith Siers-Poisson on Wed, 07/18/2007 - 10:38.

The three previous articles in this series have 
examined the 
<http://www.prwatch.org/node/6216>Politics and PR 
of Cervical Cancer in the United States. This 
fourth and final installment will look at how 
<http://www.sourcewatch.org/index.php?title=Merck>Merck's 
so-called "cervical cancer vaccine," 
<http://www.sourcewatch.org/index.php?title=Gardasil>Gardasil, 
is being marketed in Canada, Australia, and New 
Zealand.

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 
<http://www.sourcewatch.org/index.php?title=Stephen_Harper>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<http://www.cwhn.ca/> 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 
<http://www.prwatch.org/node/6216>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."

Australia

Australia 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 <http://www.csl.com.au/>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 
<http://www.smh.com.au/news/national/girls-vaccinated-against-cancer/2007/04/26/1177459878747.html>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 Zealand

In 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 Needle

In <http://prwatch.org/node/6216>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 
<http://www.sourcewatch.org/index.php?title=Edelman>Edelman 
PR firm and non-profit organizations including 
the <http://preventcancer.org/>Cancer Research 
and Prevention Foundation and 
<http://www.suwn.org/>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. 
<http://www.sourcewatch.org/index.php?title=Women_in_Government>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 
<http://www.sourcewatch.org/index.php?title=Merck>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 
<http://www.sourcewatch.org/index.php?title=GlaxoSmithKline>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.