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Cervical cancer vaccines provoke controversy in the US New York

Janice Hopkins Tanne

Two vaccines to prevent cervical cancer are nearing approval in the United States and Europe, but they are causing controversy because they are recommended for use in children aged 11 or 12, before they begin sexual activity, Dr Robert Steinbrook, a national correspondent of the New England Journal of Medicine said in a recent edition of the journal (2006;354:1109-12).

Conservative groups in the US say that use of the vaccine would encourage young people to be promiscuous. The Family Research Council, which earlier said that adolescents should be getting a message about abstinence, later said that it would support use of the vaccines but would oppose efforts to make vaccination mandatory for those attending school.

But conservative organisations may be planning state by state rather than federal campaigns against the vaccines, says a policy review by the Guttmacher Institute, an independent health research organisation (Guttmacher Policy Review 2006; 9:6-9).

A leading expert, Dr Joseph Bocchini, told the BMJ that there was no evidence that vaccinations, sex education, or instruction in condom use increased sexual activity among teenagers. In fact, he said, such education delays the onset of activity. Dr Bocchini is chief of pediatric infectious diseases at Louisiana State University in Shreveport, a member of the American Academy of Pediatrics’ committee on infectious diseases and liaison to the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Infection with papillomaviruses is common: more than six million new infections occur each year, and nearly three quarters of the US population aged between 15 and 49 have been infected with one of the papillomaviruses at some time.

Most papillomavirus infections do not cause cancer or, if they cause precancerous changes, are caught by cervical cancer screening. Nevertheless, the US has about 10 000 new cases of cervical cancer a year, and about 3700 women die. Most deaths are in poor women who have seldom or never been screened. In the developing world, where screening is less available, cervical cancer kills about 250 000 women a year and is the second most common cause of death by cancer.

The vaccines elicit the strongest immune response in people who are vaccinated young. In the US, besides approval from the Food and Drug Administration, such vaccines need recommendations from the influential Advisory Committee On Immunization Practices at the Centers for Disease Control and Prevention, which recommends when adolescents should be vaccinated and against what diseases. The committee’s recommendations are usually adopted by government agencies and determine which vaccines will be paid for by government and private programmes and which vaccinations will be required by states as a pre-requisite for students to be enrolled in schools.

The Merck vaccine, called Gardasil, is being fast tracked by the FDA and may get approval as early as June. Another vaccine, Cervigard from GlaxoSmithKline, has been submitted for approval to the European Agency for the Evaluation of Medicinal Products and will be submitted to other regulatory agencies in Asia, Latin America, and the US.

Gardasil protects against infection with the human papillomavirus types 16 and 18, which cause about 70% of cervical, anal, and genital cancers, and it protects against types 6 and 11, which cause about 90% of genital warts. Gardasil is for women and men. Cervigard is only for women. The vaccines are given in three doses and cost an estimated $300-500 (£200-300; €250-400).

"If the vaccines’ promise is fulfilled . . . they will markedly reduce the need for medical care, biopsies, and invasive procedures associated with the follow-up of abnormal [cervical smears], as well as alleviating the associated anxieties and health care costs," said Steinbrook in the New England Journal of Medicine.