National Review of Medicine: Provinces rush HPV jabs in time for school

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AUGUST 30, 2007 VOLUME 4 NO. 14

POLICY & POLITICS

Provinces rush HPV jabs in time for school

Public health experts question clinical, financial rationale

By Owen Dyer



When federal finance minister Jim Flaherty announced his budget this
spring, provincial health officials might have been forgiven for
thinking the Easter Bunny had come early.

One headline-grabber was the surprise announcement of a $300 million
package to jumpstart provincial immunization programs against human
papillomavirus (HPV), the cause of the overwhelming majority of
cervical cancers. The vaccine, Gardasil, protects against HPV types 6,
11, 16 and 18, of which the latter two are oncogenic.

All women and girls aged nine to 26 would be targeted, Ottawa said.
The provinces’ delight abated somewhat after they did the sums, and
realized that $300 million would only cover enough $425 shots to give
one to each girl currently in the 9-12 age group. But, putting any
ill-feelings aside, most provinces immediately set to work developing
plans to immunize young schoolgirls. This summer Ontario, Nova Scotia,
Newfoudland and PEI announced programs to start with this school year;
BC may also have a program ready in time.

TOO SOON?
Doctors, parents, politicians, drug makers, everyone was happy — until
this month, that is, when a bombshell landed on the CMAJ website. Four
experts in epidemiology and women’s health asked a number of pointed
questions about the evidence base, the lack of clear stated goals and
the haste with which these decisions are being made. The article
appears in the August 28 print edition, which is largely devoted to
HPV.

“My concern was with the medical evidence,” says lead author Abby
Lippman, PhD, an epidemiologist at McGill. “I couldn’t understand why
there was suddenly such a rush to do this when cervical cancer only
kills about 400 people a year in Canada, and most of them are dying
because of lack of treatment. I couldn’t see anything like the sort of
evidence one would expect to support a decision like this.”

The criticisms are of a sort we hear all too often these days. The
available research data comes from the manufacturer’s trials. The
longest follow-up was only five years. The least research was
conducted in the very age group we are now about to immunize, girls
aged 9-12. Only about 100 girls in this age group were trial subjects,
and they had the shortest follow-up.

“If we don’t know the duration of the vaccine,” says Dr Lippman, “how
can we predict the costs of the program?” She also points out that no
statement has yet defined the goals of the program. “Is it herd
immunity they’re after? If so, they should be looking at immunizing
men and boys too. Is it a reduction in cervical cancer? Gardasil only
eradicates the HPV types responsible for slightly over twothirds of
cervical neoplasms.” Above all, she asks, what’s the rush? “Most
people get HPV at some point, and it clears spontaneously in the vast
majority of cases. There is no epidemic of cervical cancer. The
Canadian Immunization Committee (CIC) is bringing out recommendations
on HPV at the end of the year. Why couldn’t they wait for that?”

The federal co-chair of that committee, Dr Theresa Tam, an infectious
disease specialist who also heads the Immunization and Respiratory
Infections Division of the Public Health Agency of Canada,
acknowledges gaps in the knowledge. “It’s true that for the primary
endpoint, cervical cancer, there is no direct data from the youngest
girls, because it would be unethical to conduct the necessary
investigations in that age group,” she says. “So antibody response is
used as a ‘bridging indicator.’ But in fact, the antibody response was
particularly good in the youngest girls. That’s a very promising
sign.” Schoolgirls are a “captive audience” who give a program “more
bang for the buck,” she notes. “Once they’ve left school, immunization
becomes hit-and-miss.” She acknowledged the dearth of follow-up data
beyond five years. “We don’t rule out booster shots in the future,”
she says, adding that shots for men and boys are also theoretically
possible. She has no problem, though, with provinces getting started
now. “Our recommendations will hopefully serve to bring some
consistency on the national level.” As for the program’s goal: “There
will be a clear statement on the program goal when CIC finishes its
work,” says Dr Tam, “but I’m afraid I can’t pre-empt it.”

“I found the CMAJ article to be full of useful information,” adds Dr
Tam. “We did look at these questions, the potential downsides, the
gaps in the knowledge, but at the end of the day we felt we still had
a very good vaccine here.”

The medical debate over Gardasil, however, has become subsumed in a
larger political fight. The trouble began south of the border.

GOV’T CONFLICTS
All of the proposed programs in Canada are comprehensive but
voluntary. In the US, the push was to get states to pass mandatory
vaccination laws. The first state to actually do so was Texas. It then
emerged that Texas governor Rick Perry received $5,000 for his
campaign from Gardasil’s manufacturer Merck on the day he met with
aides to discuss the project. Several Texas lawmakers also got
payments. The state legislature has since overturned the plan.

The same thing was happening in dozens of states considering mandatory
programs. The end came swiftly, with a letter from the American
Academy of Pediatrics asking Merck to desist in its lobbying, because
it was doing more harm than good. The company agreed.

There’s evidence something similar has been going on here. CanWest
investigative reporter Shelley Page discovered that shortly before the
budget announcement, a former aide to Prime Minister Stephen Harper,
Ken Boessenkool, registered as a Merck lobbyist. Shortly before
Ontario announced its immunization plan, Jason Grier, former executive
assistant to Ontario’s health minister George Smitherman, had also
registered as a Merck lobbyist. The Society of Obstetricians and
Gynaecologists of Canada came out in support of the program, but they
also acknowledged that their research on the issue had been funded by
a $1.5 million grant from Merck.

“I’m not saying that HPV immunization is necessarily a bad thing,”
says Dr Lippman. “I am saying this is no way to make major public
health decisions.”