TORONTO (CP) - Kristin Peterson has no qualms about getting her
13-year-old daughter vaccinated against human papillomavirus, or HPV.
Peterson only wishes that Evangeline, who started Grade 9 this month in Toronto,
could get the vaccine through the publicly funded program Ontario and three
other provinces are rolling out this month.
The Ontario government is offering the expensive vaccine to girls in Grade 8
only, with no catch-up program for Grades 9 through 12. And that means Peterson
will have to shell out several hundred dollars to have her family doctor
vaccinate Evangeline.
"I think it's my responsibility. I do," she says, noting her daughter's aunt had
cervical cancer.
But not all parents of eligible girls feel as confidently disposed towards the
HPV vaccine being offered in Ontario, Nova Scotia, Newfoundland and Labrador and
Prince Edward Island this year. (Other provinces and territories are still
deliberating whether and when to implement a program.)
There's a buzz of uncertainty as parents study information packets and release
forms that would give public health officials the go-ahead to administer the
three-shot vaccine to girls in Grade 6 in P.E.I and Newfoundland and Labrador,
Grade 7 in Nova Scotia or Grade 8 in Ontario.
Early, aggressive lobbying by vaccine manufacturer Merck and Co., parent company
of Merck Frosst Ltd. Canada, and the unexpectedly quick decision by Ottawa to
funnel $300 million to provinces and territories for school-based HPV
immunization programs, have left a cloud of suspicion over this vaccine.
Commentators muse aloud about why an HPV vaccine made it onto the publicly
funded list so quickly and whether the machinations of Big Pharma - Merck has
been locking up sales before a competitor's vaccine hits the market - or the
federal Conservatives, still seeking majority government status, have run
roughshod over the interests of teenage girls.
"There is no epidemic of cervical cancer in Canada to warrant the sense of
urgency for a vaccination program," several researchers wrote in a widely
discussed commentary published last month in the Canadian Medical Association
Journal.
The Canadian Cancer Society estimates that 1,350 women will be diagnosed with
cervical cancer this year in Canada and 390 will die of the disease.
Questions such as how long the vaccine protection will last and how well it will
work in young girls remain to be answered, noted the team, led by McGill
University epidemiologist Abby Lippman. They also raised the concern that the
vaccine may create a false sense of security in girls, leading them to ignore
the need for safe sex and regular Pap tests for cervical cancer detection.
"It is time to take a breath and reflect on what we know and what we don't know,
and to develop a plan based on solid, reliable evidence that adds value for
everyone," they argued.
Others have questioned the side-effect profile of the vaccine. To date, most
reports suggest mainly mild reactions typical of other vaccines. But if a new
vaccine carries a risk of one-in-a-million type adverse reactions, that will
only become apparent after millions are injected with it.
"There's no reason to think that there's going to be rare, serious adverse
events from the vaccine that haven't come up so far in the clinical trials, but
you never know until the data's in," says Dr. John Schiller, a senior
investigator with the U.S. National Cancer Institute and one of the inventors of
the vaccine.
Still, for others there are enough answers to proceed.
"The science is there," says Dr. Robert Strang, Nova Scotia's chief public
health officer. "It's been approved by the federal government and NACI (National
Advisory Committee on Immunization) and the money is there.
"In Nova Scotia, we were able to bring the key people around the table for
implementation and so there was no reason not to go ahead this year."
Dr. David Williams, Ontario's associate chief medical officer of health, is
bemused that people feel the decision to add HPV vaccine to publicly funded
programs is rushed.
He says the public health community has been watching the progress of these
vaccines for years as they've made their way through the various stages of
clinical trials - the same types of clinical trials that preceded licensure of
other new vaccines against chickenpox or Prevnar, the pneumoccocal vaccine.
"They all had the same rigours of scientific research required for both FDA (the
U.S. Food and Drug Administration) and also for the bureau of biologics of
Health Canada to license them," said Williams. "So that's why it's odd that they
say this one is much more rushed."
Dr. Joan Murphy worries the debate is losing sight of the fact that clinical
trials suggest both Merck's Gardasil and the yet-to-be licensed Cervarix, made
by GlaxoSmithKline, are highly effective at preventing infection by two of the
strains of HPV that are responsible for more than 70 per cent of cervical
cancers.
"You try to give your kid a good diet so he'll be healthy when he's 30 or 40 or
50, don't you?" says Murphy, who chairs a task force on cervical cancer
prevention for the Gynecological Oncologists of Canada. "You try to plan for
health in the future. "This is no different. It's just that it's about sex - and
bugs.
"My colleagues and I treat women with cervical cancer all the time," continues
Murphy, who is head of gynecological oncology at Toronto's University Health
Network. "And it's heartbreaking, especially when there's a poor outcome, to
know that it likely didn't need to happen."
Interestingly, Schiller isn't troubled by the debate. He understands that
parents would feel more comfortable about this vaccine if it had already been
used in millions of people.
"That's just human nature and it's a reasonable approach to have," says Schiller
who, along with research partner Dr. Douglas Lowy, did much of the early stage
development of the HPV vaccine.
The U.S. government, which employs Schiller and Lowy and which holds the patent
for the vaccine, licensed it to both Merck and GSK. As inventors, Schiller and
Lowy receive limited royalties as set out by government regulations.
"Our cap is so low that they wouldn't have to hardly sell anything for us to
reach our cap," Schiller explains. "We really don't have a big vested interest
in it."
He sees a benefit of debate on the vaccine, saying it is putting the issue of
HPV and cervical cancer on the public's radar screen.
"We couldn't be, overall, more pleased," Schiller admits. "There's never been a
vaccine against a sexually transmitted vaccine that's even worked middling and
this is working great.
"In terms of the disease end point, it's virtually 100 per cent. And the other
thing is there's a lot of debate about all this sort of stuff, but the bottom
line is . . . the majority of U.S. families - and my assumption is Canadian
families - will adopt this vaccine and accept it."
