Not since the Salk vaccine was triumphantly unveiled in 1955 as the miracle drug that would end the scourge of polio has there been as much hoopla surrounding a vaccine as there is today about one that is being touted for having the potential to eradicate cervical cancer.
Unlike polio, where children were dying and crippled in large numbers and immunization stopped an epidemic in its tracks, cervical cancer develops slowly and the positive or negative effects of a vaccine for human papillomavirus (HPV), which can cause cancer of the cervix, will not be seen for decades.
There remain many unanswered questions about the vaccine: Will it actually prevent cervical cancer or just prevent infection with some strains of the virus? Will it confer long-term protection or will booster shots be required? Should boys be vaccinated?
How many doses are needed - three, or just two? And will the arrival of a competitor to the Gardasil vaccine, called Cervarix, bring down prices?
Conservative politicians have embraced the drug as a means of bolstering their street cred, and winning women's votes. The more liberal politicians - traditional supporters of public health measures like immunization - have railed about a Big Pharma conspiracy to ram Gardasil down our collective throats with sleazy lobbying and slick tug-at-the-heartstrings marketing.
Regardless of your take, the fact remains that since polio, no vaccine has gone from regulatory approval to mass use in government-funded programs with such dizzying speed.
Health Canada approved Gardasil on July 18, 2006. The National Advisory Committee on Immunization gave the vaccine a thumbs-up on Feb. 15, recommending that all girls between 9 and 13 receive the drug. Then the Canadian Immunization Committee, a federal-provincial-territorial body whose role is to determine that vaccines that are effective and cost-efficient are made available equitably to all Canadians, set to work to determine if the expensive new vaccine should be publicly funded and included in routine school-based immunization programs.
But on March 19, during his budget speech, Finance Minister Jim Flaherty short-circuited the scientific and economic discussions by announcing $300-million to kick-start an HPV vaccination program.
Ottawa's move stunned public health officials, as well as the provinces. They were thrilled by the money, particularly for a vaccine that the public was clamouring for, but alarmed by the manner in which the decision was made.
"Aside from the polio vaccine in the fifties, it was the first time that the federal government made a direct medical decision," said Noni MacDonald, an infectious disease specialist and professor of pediatrics at Dalhousie University in Halifax.
"This has caused a lot of us in public health and medical circles to flinch," she said.
The discomfort was made even greater when Ontario Premier Dalton McGuinty announced last week that the province will undertake mass HPV vaccination of Grade 8 girls at the beginning of the school year. Again, the breakneck speed of implementation is noteworthy.
Yet, in Toronto as in Ottawa, these scientific and pharmacoeconomic debates, not to mention the necessary public health logistical planning, appear to have been overtaken by the desire to score political points with soccer moms. (Ontario voters go to the polls in October.)
Sandra Pupatello, the Ontario Minister of Women's Issues, dismissed the criticism, saying her government was practising good public policy, not political opportunism.
"There has never been an issue around women's health that has had this level of unanimity. It wasn't a difficult decision."
Dr. MacDonald said that while the vaccine that prevents the transmission of some strains of HPV may well prove to be a godsend and that public health officials are grateful for the money and attention afforded vaccination (usually the poor, neglected cousin of hi-tech medicine), the precedent is disturbing.
"Why are politicians making medical decisions? This is not how health-care delivery should be decided."
Anne Rochon Ford, co-ordinator of Women and Health Protection, agrees. The lack of transparency in a program that could have a dramatic impact on women's health is troubling, she said, and doubly so because governments seem to have succumbed to backroom lobbying from the massive marketing campaign of Gardasil's maker, Merck Frosst Canada Ltd., and its international parent.
"It is staggering how quickly and secretly this has all happened and that points to some pretty active footwork behind the scenes," she said.
Ms. Rochon Ford said the rhetoric about the vaccine with no long-term track record has been unbelievable, and the media has mindlessly and uncritically parroted outrageous claims, while ignoring the importance of proved measures of reducing cervical cancer like Pap testing.
The result of all the attention to Gardasil has been to drive public demand. A poll released earlier this week showed that 81 per cent of parents want their daughters to get the vaccine and 77 per cent favour a universal, school-based program.
And, even without a free vaccine program in place and despite its high price, the drug's maker has already sold 150,000 doses of Gardasil, an unprecedented amount.
"What has happened here is a milking of public sentiment around the fear of cancer and politicians, along with some other well-meaning people, have bought into it," Ms. Rochon Ford said.
Many in the public health and medical fields share those views but are afraid to speak up, lest they be seen as kicking a gift horse in the mouth.
There is also a school of thought that all the machinations can be forgiven because, ultimately, the right decision was made.
"Yes, the process has been manipulated and politicized but let's not lose sight of the fact that this is a good vaccine and a great advance - immunization against a cancer," said Joan Murphy, past president of the Society of Gynecologic Oncologists of Canada and a member of the cervical screening collaborative group at Cancer Care Ontario.
Provincial officials are similarly torn. Generally, they are enthusiastic about the vaccine but miffed at Ottawa's intrusion and dismayed at their inability to review and judge Gardasil like any other new drug vying for funding.
But, again, no one wants to raise seemingly bureaucratic arguments when discussing a vaccine that may prevent a nasty form of cancer.
Yet, there are real effects from the politicization of the process.
Nova Scotia, Prince Edward Island, Newfoundland and Labrador and Ontario will begin vaccinating girls against HPV this fall. British Columbia and Quebec will likely do so beginning in the fall of 2008, and other provinces and territories have not yet decided.
"There are troubling inequities," said Karen Pielak, past chair of the Canadian Nursing Coalition for Immunization. And worse yet, the entire system designed to avert those inequities - children receiving vaccines in one province but not another - was circumvented.
Ms. Pielak, a member of the Canadian Immunization Committee, said all provinces and territories agreed to a come to a common position on introduction and funding of the HPV vaccine, but that fell apart.
"There was an opportunity for political gain and it looks like that took priority over everything else," she said.
Now, in the place of scientific debate and planning, there is a rush to the gates to see who gets to vaccinate girls first.
B.C. has decided to wait a year, largely for logistical reasons. "The nurses said you can't do it this fall and, thankfully, their voice was heard loud and clear," Ms. Pielak said.
Paradoxically, the jurisdictions that have opted to follow the rules to ensure they are implementing HPV vaccination for the right reasons are being viewed as laggards and cheapskates.
"Traditionally, Alberta has led the pack on immunization so people are wondering why we opted to wait on HPV," said Karen Grimsrud, deputy provincial health officer for Alberta.
She said the priority is to review the vaccine thoroughly, like any other, and that it is important not to compromise other important public health programs.
Rushing to vaccinate girls in the fall could, for example, undermine influenza vaccination. The arrival of Cervarix could also bring down prices and make the HPV program more cost-effective, Dr. Grimsrud said.
Finally, and most important, she said that it is essential to prepare an education campaign to ensure that there is good uptake of the vaccine and that there are not negative spinoffs, like young women thinking that Pap tests are no longer necessary.
(HPV is so pervasive that virtually everyone will be infected at some point in their lifetime. In most cases, the body's immune system clears the virus, as it does a cold, but in a minority, the virus lingers and can cause cancer. The vaccine only prevents four strains of HPV, so infections and the risk of cancer will continue even with the vaccine. For all those reasons, women are being urged to continue routine Pap testing.)
"The last thing we want is a program that's not fully thought through," Dr. Grimsrud said. "If you're going to do this, you should do it right."
Yet, the momentum to vaccinate, to invest billions of dollars in the HPV vaccine, seems unstoppable.
The hope of supporters and detractors alike is that as girls start lining up for their needles in the fall, the discussion does not die, but moves to a higher level.
"I hope that the momentum for cervical cancer prevention won't die once we vaccinate," Dr. Murphy said. "We can't allow the message that screening [Pap testing and newer technologies]is necessary and must continue to be forgotten."
Ms. Rochon Ford has a similar wish.
"The vaccine may prove to be a smart thing in a few years but it's not a magic bullet," she said. "We still need to teach girls, and boys, about preventive contraception, about Pap tests, and about health inequalities.
"I hope the moms of 12-year-olds who are worried about cervical cancer don't lose sight of that reality."
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How cancer can start
HPV is the most common sexually transmitted infection. There are more than 150 types of HPV, about 40 of which can cause cancer.
HOW THE VIRUS INFECTS
1- Virus enters cervix cell, sheds shell and releases DNA.
2- DNA instructs cell to make viral proteins.
3- Proteins keep infected cells growing for years; some may become cancerous.
HOW THE VACCINE STOPS IT
1- Vaccine particles carry protein that mimics virus protein.
2- Body reacts to protein and makes antibodies.
3- Later, if virus enters body during sex with an infected partner...
4- ...antibodies attack virus and keep its DNA from escaping.
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HPV vaccine facts
The human papillomavirus is the world's most common sexually transmitted infection.
HPV is so pervasive that virtually everyone who is sexually active will be infected at some point in their lifetime. In most cases, the body's immune system clears the virus, as it does a cold, but in a minority, the virus lingers and can cause cancer.
There are more than 150 types of HPV, about 40 of which can cause cancers; in addition to cervical cancer, HPV can cause penile, vulvar, anal, oral, pharyngeal, and head and neck cancers.
Scientific research has focused on a handful of strains of HPV. Types 16, 18 and 45 are, between them, responsible for 70 per cent of cancers of the anogenital tract; types 6 and 11 account for about 90 per cent of genital warts.
Gardasil, a product of Merck Frosst Canada Ltd., is a quadrivalent vaccine, targeting four strains of HPV - types 6, 11, 16 and 18.
The vaccine requires three doses. Purchased privately, it costs $134.50 per dose, plus dispensing fees.
Cervarix, a vaccine from GlaxoSmithKline Inc., is expected to be approved later this year. It also targets HPV types 16, 18, and may provide some protection against 31 and 45. Its price has not yet been set.
When governments make mass purchases of vaccines, they typically receive discounts of 40 to 70 per cent off of the list price. The $300-million set aside by Ottawa in the HPV Fund is available to the provinces on a per capita basis. It is designed to cover the cost of vaccinating one age group of girls (it will be given to girls some time between age 9 and 13, or Grade 4 to 8) for one year. Afterward, provinces will have to assume the costs.
André Picard
VACCINATION - BY PROVINCE
In recent weeks a number of provinces have announced if and when they plan to vaccinate girls against HPV. Newfoundland and Labrador: Fall, 2007; Grade 6 (2,800 girls);
$1.5-million a year
Prince Edward Island: Fall, 2007; Grade 6
New Brunswick: no decision
Nova Scotia: Fall, 2007; Grade 7 (6,000 girls)
Quebec: no decision
Ontario: Fall, 2007; Grade 8 (84,000 girls) no catch-up;
$39-million a year
Manitoba: no decision
Saskatchewan: no decision
Alberta: no decision
British Columbia: Fall, 2008; Grade 6 and catch-up in
Grade 9 for next three years (50,000 girls); $18-million a year
Yukon: no decision
Northwest Territories: no decision
Nunavut: no decision
André Picard