$300 million earmarked for HPV vaccine

Gardasil is a three-course vaccination produced by pharmaceutical giant Merck Frosst and is aimed at preventing the human papilloma virus, which causes cervical cancer in women The company recommends the vaccine for all girls between the ages of 9 and 26 and has lobbied for states and provinces to make it mandatory for girls in Grade 6 to receive it.

Texas, Virginia and New Mexico were on board early in mandating the vaccine, although Maryland, Michigan and Mississippi defeated or abandoned such ideas after lobbying from concerned parents and the medical community.

Last year, Texas Governor Rick Perry bypassed the conservative state legislature and signed an executive order mandating all sixth graders in the state be immunized against HPV using Gardasil. Shortly thereafter, the Associated Press revealed that Mike Toomey, a former chief of staff to Governor Perry, was one of Merck’s chief lobbyists in the state.

Likewise in Canada, Merck hired Ken Boessenkool of Hill and Knowlton, a public relations firm, to lobby the federal government. According to Wikipedia, Boesenkool was the senior policy adviser to Conservative leader Stephen Harper, with responsibility for message management during the 2004 federal election campaign.

Some social conservatives on both sides of the border – Concerned Women for America in the U.S. and the Christian Heritage Party in Canada – have criticized the plan to make Gardasil mandatory because they believe that by lowering the risks associated with pre-marital sex, teenage girls will have their first sexual encounters earlier and become more promiscuous. Economists understand that there are non-economic incentives and disincentives, but it is hard to imagine a randy 13-year-old doing a cost-benefit analysis that includes the likelihood of contracting cancer-causing HPV before deciding to have sex.

There are, however, other, more valid criticisms of the costly program.

LifeSiteNews.com reported that a National Advisory Committee on Immunization in the Canadian Communicable Disease Report report said: “Gardasil is recommended for females between 9 and 13 years of age, as this is before the onset of sexual intercourse for most females in Canada and the efficacy would be greatest. While efficacy of the vaccine in this age group has not been demonstrated, the immunogenicity bridging data implies that efficacy would be high.”

Get past the medical jargon and you realize that there is a push for Gardasil to be used despite the fact that it has not been adequately tested on pre- or young teens. While Gardasil has been tested for effectiveness among young women 12-13 years old, it was tested only for immune response, not the efficacy of the drug in preventing the virus or cervical cancer.

The (U.S.) National Vaccination Information Centre has accused Merck and the Food and Drug Administration of irresponsibly  “fast-tracking” the vaccination without being acknowledging or understanding the possible side-effects of usage, particularly among young girls. NVIC’s president Barbara Loe Fisher said, “Nobody at Merck, the CDC or FDA knows if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine – will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults.”

According to a 2006 NVIC report, 60 per cent of those participating in U.S. clinical trials experienced headache, fever, nausea, dizziness, vomiting or diarrhea, while a smaller number experienced more serious side effects included gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis. Also, 17 patients died during the clinical trials.

According to a Washington Times story earlier this year, Gardasil is aimed at the wrong age bracket. Considering the drug’s proven five-year effectiveness, most girls will be susceptible to HPV at 18. Yet, the Centres for Disease Control and Prevention finds that the typical cervical cancer patient is 47 and that she contracts the virus in her 30s. Will women who were immunized in Grade 6 return for their Gardasil shots in university and every five years thereafter? And who picks up the bill for the $360 drug regimen then?

In other words, the Conservatives may have dedicated $300 million to a program that might not work and even if it does, might harm young women. However, even if Gardasil were 100 per cent as effective among the targeted age group as it has been among young adults it has been tested upon, there would still be gaps in HPV-related cervical cancer because the drug regimen is effective against only four types of HPV (including HPV 16 and HPV 18) that are responsible for 70 per cent of cervical cancer cases.

Furthermore, there are fewer than 400 cervical cancer deaths each year in Canada, with about 1,300 new cases each year. The Vancouver Sun has reported it might be more cost efficient to ensure immigrants, minorities and the poor have regular access to Pap tests, which has demonstrated success at reducing cervical cancer deaths – perhaps as much as 80 per cent over the past half-century.

There is still a moral argument against Gardasil: mandating such vaccines usurps the right of parents to make medical decisions. Because HPV is not like polio or chickenpox in how its spread – to get it, one must partake in a particular risky behaviour: sex – there is no compelling public safety reason to require all teenage girls get it. Parents and physicians who know the behaviour of their doctors and patients are best suited to make the decision about whether exposing a young girl to an untested vaccine is in her best interest. Focus on the Family in the U.S. has endorsed making Gardasil available, but opposes making it mandatory. This seems to be in opposition to Concerned Women’s argument that immunizing against HPV could lead to increased risk-taking among young teenage girls.

HPV is estimated to afflict 20-30 per cent of college-age women and up to 20 per cent of women in their child-bearing years.