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Gardasil, the world’s first vaccine against the disease, was launched here last week. Although GPs are theoretically able to prescribe it on the NHS, most are likely to wait for guidance from the Department of Health, and most prescriptions in the near future are likely to be private, costing around £450 for three doses. But experts believe that by this time next year a programme will be in place to vaccinate girls in their first year of secondary school — at a cost of around £90 million annually.
An opinion poll of the parents of girls under 16, conducted for the cervical cancer charity Jo’s Trust and published this week, found that 82 per cent approved of their daughters being vaccinated at the age of 12.
Each year in the UK, around 3,000 women develop cervical cancer and 1,000 die. Gardasil acts against the four strains of the human papillomavirus (HPV) which cause 75 per cent of cases, and it has been estimated that a successful vaccination programme could reduce these figures by up to two thirds. The vaccine is administered before recipients are sexually active: it must be given before exposure to the virus, and the immune response is much better in children than young adults.
Last month, the state of Michigan became the first place in the world to require female pupils to have the new HPV vaccine, after Food and Drug Administration (FDA) approval of Gardasil: other US states are expected to follow suit.
While experts are enthusiastic about this development, many are asking why the vaccine is being restricted to girls. Cervical cancer may be confined to women but it is transmitted through sexual contact: the more sexual partners a woman has, the greater her chances of contracting the disease, and a monogamous woman’s risk is increased if her partner has had other sexual relationships.
“Vaccinating only girls is a shortsighted and potentially damaging strategy,” says Dr Anne Szarewski, a clinical consultant at Cancer Research UK. “It makes obvious sense that both boys and girls should be vaccinated. But most countries are likely to start by vaccinating girls because it is cheaper.” A recent editorial in The Lancet took the same line, making a comparison with rubella (German measles) , another illness that predominantly affects women, causing foetal abnormalities when contracted in pregnancy. According to the publication: “In 1995, the UK’s rubella immunisation programme was modified after 25 years to include boys as well as girls, after a rise in the number of pregnant women contracting rubella. For effective and long-term eradication of HPV, all adolescents must be immunised.”
The aim of any vaccination programme is to attain “herd immunity”: a level of immunity so high that an infection cannot spread. If all girls were vaccinated, this might be achieved (though the rubella example suggests not), but Dr Szarewski thinks that the chance of blanket coverage in women is small. “If you combine the number of parents who are worried about vaccines generally with those who have moral and religious objections to their daughters being vaccinated against a sexually transmitted disease, this may well affect 25 per cent of girls,” she says. “One mathematical model shows that if the uptake of the vaccine among girls falls below 75 per cent it is cost-effective to vaccinate boys.” Vaccinating only women also reinforces the idea that sexual health is a solely female concern and that nice girls are not at risk, Dr Szarewski fears.
The UK’s highly effective screening programme has cut the number of deaths from cervical cancer by half, but the toll exacted by the disease remains high. Elaine Davies, a 41-year-old mother of two young sons from Halifax, was first found to have it in 2002 — two years after her last cervical smear test — and endured a recurrence a year later. The cancer was finally excised in an operation that lasted 16 hours and involved a rota of three surgeons, the transfusion of 20 pints of blood and the removal of Elaine’s bladder, vagina and part of her bowel.
“People think that if your smear is abnormal you have a few cells lasered and that is it,” she says. “This is a killer disease which affects mainly young women. Three years after my operation, my body is a patchwork of hideous scars: one runs down from my left breast to my bikini line. I carry around a bag full of urine, which has led to kidney problems — though they have managed to rejoin my bowel — and I can no longer have full sexual intercourse with my husband. I have had a hysterectomy and my ovaries died during radiotherapy. But I am alive. Four of the friends I have made since having this disease have died. Despite what happened to me, I am very in favour of smear tests, but a vaccination programme will certainly save lives.”
Such a programme would also reduce the anxiety caused by an abnormal smear result. Thanks to screening, only a tiny proportion of those who contract HPV go on to develop malignancies. But Britain has one of the highest levels of HPV infection in the world, largely because we have so many sexual partners: a report from the Institute of Public Policy Research, to be published next month, reveals that our teenagers are the most sexually active in Europe. The consequences of this behaviour should not be underestimated.
Each year, abnormal results from a cervical screening lead to more than 128,000 women having a colposcopy, during which the cervix is viewed through a low-powered microscope and a biopsy is taken. In some cases, treatment may be performed at the same time.
“My patients tell me this is at best uncomfortable and at worst intensely painful,” says Dr Sarah Jarvis, a spokesperson on women’s health for the Royal College of General Practitioners. “Following treatment, which involves the removal of a small area of the cervix, there is a risk of infection and a slightly higher chance of having a second-trimester miscarriage in subsequent pregnancies. Reducing the number of abnormal test results would mean a lot less misery for women.”
The number of colposcopies should be reduced by at least half once the vaccination programme is running, says Margaret Stanley, professor of epithelial biology at Cambridge University. She adds: “If boys are immunised the decline will come earlier and faster.” Should men balk at being vaccinated to protect their womenfolk, it may be possible to appeal to their selfish side. Gardasil is also highly effective in women against HPV 6 and 11, which cause 90 per cent of genital warts, costing the NHS around £23 million a year in treatment. Early evidence suggests that it will be equally successful in men.
“Men want to avoid genital warts,” says Professor Stanley. “They are irritating, unsightly, tend to reoccur and have a significant effect on sexual life. And treatments are unpleasant.” Trials on males are not yet complete and no country will give the green light to vaccinating boys until the statistics are on the table.
Immunising only girls also leaves gay men unprotected. Most cases of cancer of the anus and penis — of which there are about 400 each in the UK annually — are caused by infection with HPV 16 and 18 during homosexual intercourse and would be prevented by Gardasil.
Ultimately, any decision on whether to include boys in a vaccination programme is likely to be taken on cost grounds. One study has suggested that vaccinating boys would reduce cervical cancer rates by 2 per cent at 31 times the cost of immunising girls alone. However, Geoffrey Garnett, the professor of microparasite epidemiology at Imperial College, London, says that more data specific to the UK is needed before decisions are made.
“A lot more work needs to be done on how the vaccine would be introduced here and what parental response rates would be,” he says. “The higher the coverage in girls, the lower the impact of vaccinating boys. I think it’s likely we will have a school vaccination programme by the end of next year, but it is too early to say exactly what form that will take.”
Interestingly, although FDA approval for Gardasil covers only females, the European licence is for boys and girls aged between 9 and 16 and for women up to 27. There have been suggestions that, in these circumstances, giving it only to girls may be discriminatory.
Whatever happens, experts are adamant that the vaccine should not be a substitute for screening. Not only will it be many years before all women are protected by the vaccine, but Gardasil — like its GSK rival Cervarix, due out next year — is not effective against all cancer-causing strains of HPV. “Screening should change to take account of the vaccine, and may become less frequent, but it will still be needed,” predicts Prof essor Garnett.
For more information: www.jotrust.co.uk
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