CHILDREN and vaccines can be a controversial combination when it comes to forming public policy. Where the vaccine concerned is designed to protect against a sexually transmitted infection, expect fireworks.
The Republican governor of Texas, Rick Perry, is feeling the heat from religious groups and concerned parents after signing an order on 2 February requiring 11 and 12-year-old Texas schoolgirls to be given a new vaccine called Gardasil. It protects against human papillomavirus (HPV) types 6 and 11, which cause cervical warts, and HPV 16 and 18, which cause two-thirds of cases of cervical cancer. At least 18 other states are considering similar action. Eventually, if supporters have their way, the entire female population of the US 鈥� around 150 million 鈥� will be compulsorily vaccinated.
Europe is likely to follow suit. The European Commission approved Gardasil in September 2006, following approval of the drug by the US Food and Drug Administration (FDA) in June. A special panel of the UK government鈥檚 expert advisory body on vaccination is due to meet this month to consider proposals for a nationwide HPV vaccination programme for schoolchildren similar to that taking shape in Texas.
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Many parents feel that a vaccine for sexually transmitted diseases interferes with the way they raise their children. Indeed, Gardasil seems an odd vaccine to choose as a requirement for school entry, since HPV is not spread by ordinary day-to-day contact. Issues of civil liberties and religious freedom aside, there are also serious clinical and policy questions over whether it should be administered to children in this way.
The first issue is safety. Is Gardasil really as safe and effective as Merck, its manufacturer, and the FDA claim? In a clinical trial of 11,000 individuals, the rate of immediate side effects was indeed low 鈥� about 1 per cent 鈥� but little is known about its long-term effects. The health of the trial participants was monitored for no more than four years, and in the case of 11 to 12-year-olds, who are the most vulnerable group, for only 18 months. This will mean that the first groups of compulsorily vaccinated schoolgirls will in effect be a testing ground for the drug鈥檚 long-term safety. Gardasil may be as safe as advertised, but we should not forget Merck鈥檚 infamous anti-arthritis drug, Vioxx, which the company withdrew in September 2004 after a study found that long-term use doubled the risk of heart attacks and strokes.
The second question goes to the heart of healthcare policy. Is this the best way to spend scarce health dollars? Merck charges $360 for a series of three Gardasil injections. Administering the injections will add 18 to 25 per cent to this cost. Nationwide, the cost of vaccinating American girls with Gardasil will amount to some $800 million a year. What is the potential anti-cancer benefit? Each year on average in the US, 11,150 women are diagnosed with cervical cancer and 3670 women die from it. If HPV 16 and HPV 18 cause two-thirds of the cases, we can calculate that Gardasil will prevent almost 7500 of them, saving around 1200 lives. This is an unequivocally desirable outcome, but at $800 million per year the cost of saving each life will be over $650,000. If the goal is to save lives, there are more cost-effective ways of doing so.
This is because cervical cancer deaths are almost entirely preventable. Women generally only die of cervical cancer because they have failed to get regular cervical smear or 鈥淧ap鈥� tests, which are highly reliable in detecting precancerous lesions at an early, curable stage. A 2001 study found that 12 per cent of women aged 18 to 64 had not received any Pap screening within the previous three years. This is hardly surprising, as more than 20 million women lack health insurance and they are far less likely to have regular tests than those who do have insurance. Cervical cancer is two to three times as common among women of Mexican-American, Puerto Rican or Vietnamese heritage, who tend to be less well off, as it is among non-Hispanic white women.
The main beneficiaries envisaged for Gardasil will therefore be the children of the poor, but is it really the answer to their health problems? Surely these women would be far better served by being given access to a comprehensive national health programme that includes Pap tests on a prescribed basis, and that would also allow other diseases and conditions to be discovered and treated early. Implementing a compulsory vaccination scheme for cervical cancer merely distracts from the urgent need to implement such a system.
Rather than administer high-tech vaccines to pre-pubescent girls, it would make more sense to allocate the money this would cost taxpayers to increasing the provision of basic gynaecological services to the underprivileged. This may not be as attractive to the pharmaceutical companies, but it is a better way of caring for women in the US and elsewhere.
鈥淚t would be better to spend the money on basic gynaecological services to the underprivileged鈥�
