AUGUST 30, 2007


Provinces rush HPV jabs in time for school

Public health experts question clinical, financial rationale

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.

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.

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.”



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