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HPV inoculation may not be the right drug at right time

The reluctance of Grade 8 girls to take a controversial vaccine seems to have confounded Ontario’s public health officials.

Just 53 per cent have taken up the government’s offer of a free vaccine against cervical cancer and human papilloma virus (HPV). Since new vaccines typically have an uptake rate of greater than 80%, health officials are apparently worried the vaccine has been “a victim of bad publicity.”

But maybe it’s not the publicity. Maybe it’s just a bad idea.

Gardasil has been heavily marketed as the first anti-cancer vaccine. It claims to be 100 per cent effective at preventing cervical cancer caused by the two HPV strains that account for 70 per cent of all cases. No wonder it seems like a miracle.

Canada appears poised for the mass inoculation of an entire generation of young girls (aged 9-13). So far, Ontario, Nova Scotia, Newfoundland, PEI and B.C. have all announced or commenced vaccination programs.

Plans are being made for an Alberta HPV vaccine program, although there is no set date.

Should parents give the goahead for the vaccines? One common argument against these programs has perpetuated the fear that vaccinating nine-year old girls against sexually-transmitted diseases will make them more promiscuous. Frankly, I’m not sure how a vaccine can make sex more attractive. There are a host of other sexually transmitted diseases out there, plus AIDS and the prospects of pregnancy. Factors such as parental involvement are likely better determiners of premature sexual activity than Gardasil.

Another simplistic argument is the naive acceptance that since Gardasil prevents cancer, it should have a free pass into the public health system. As you’ll see below, even anti-cancer drugs can be problematic.

But before we undertake this massive endeavour, the public discussion needs to go beyond the declaration that Gardasil prevents cancer.

Clinical trials studied 20,000 women (aged nine to 26). But only 1,200 of those were in the age group of nine to 15, and the youngest participants were only followed for 18 months. It defies common sense, but that means there isn’t much data on how the vaccine affects the very age group that is now being inoculated.

Another unknown is how long the vaccine will last. It could last up to five years, but that will vary significantly with individuals. So, in about four years or so, there may be a lot of sexually-active teenagers who may be vulnerable to HPV — while thinking they are protected. They just don’t know. A booster shot is possible, but it’s never been tried or studied.

There are other reasons to question the adequacy of Gardasil’s five-year study. It claims a success rate of 70 per cent in preventing cervical cancer and nearly 100 per cent in preventing precancerous lesions. But the average time for cancerous lesions to develop is eight to nine years. In fact, it can take decades for lesions to develop into an invasive cancer.

So, how can a five-year trial claim to be 100 per cent effective in preventing a cancer that takes more years to develop? Many claim that the high rate of HPV is enough reason to greenlight Gardasil vaccinations. Some 75 per cent of sexually-active Canadians will get HPV during their lifetime — but not every infection of HPV causes cancer. In fact, only two per cent of infections will result in precancerous lesions. Cervical cancer is also relatively rare, with 1,400 new diagnoses (and 400 deaths) each year. I don’t mean ignore the significance of each death or diagnosis, but based on rates of cancer associated with HPV, it’s difficult to accept the claim that high rates of HPV call for mass — or mandatory — inoculations of Gardasil.

Finally, there are concerns associated with the drug manufacturer Merck Frosst. You may recall it as the maker of another supposed “miracle” drug — Vioxx. The painkiller was phenomenal in killing the pain, but it was eventually pulled from the market after it was found to cause heart attacks and strokes. It was later shown that Merck knew of the problem during the clinical trials, but neglected to mention it.

So, Merck’s reputation is questionable at this point — and Gardasil stands to generate billions of dollars in revenue for a company that is now paying out billions in legal settlements.

Merck also reportedly gave a financial ‘grant’ of $1.5 million (ostensibly for HPV education) to a group of Canadian medical specialists that subsequently came out strongly in favour of Gardasil. It’s also been reported that Merck hired a former insider in the Prime Minister’s Office to lobby the federal government for financial backing for mass inoculations. That’s exactly what happened as the feds forked over $300 million. It’s a rather large sum for a stingy government and a relatively rare cancer.

I’m not adamantly opposed to an HPV vaccine. It could potentially be very beneficial. But is it worth the risk to the health of our daughters when we don’t have answers to some of the basic questions raised above?

I’m not convinced that this is the right drug and the right time. We might be going ahead for the wrong reasons (what better optics than handing out an “anti-cancer” vaccine to all Canadian women?) and I’m not convinced that we know enough about the long-term effects of Gardasil to allow governments to make guinea pigs out of our children.

Susan Martinuk
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