News on Women's Health

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Science  21 Jul 2006:
Vol. 313, Issue 5785, pp. 273
DOI: 10.1126/science.1132381

A piece of important and encouraging news for the world's women and their health has recently arrived from the world of clinical trials. The results of a carefully structured controlled trial have persuaded the U.S. Food and Drug Administration (FDA), with strong endorsement from an advisory committee, to approve a vaccine that is effective against the two forms of human papilloma virus (HPV) that are most likely to lead to cervical cancer. 3700 women die of this disease annually in the United States, but the mortality is far, far greater in the developing world, where this vaccine could provide a major public health benefit. Thus there is strong international interest in this result, and approval processes are under way in a number of countries. Here in the United States, which individuals receive immunization, when they get it, and where, are problems that await resolution in potentially heavy ethical weather.

The new vaccine, developed as a result of research done in the United States and other countries, has resulted in the development of competing products by Merck & Co. and Glaxo-Smith-Kline (GSK). The Merck entry, which was the subject of the recent FDA approval for vaccination of girls and young women between the ages of 9 and 26, is called Gardasil. It is effective, but it is not cheap; the manufacturer says it will cost about $360 for the three doses that will be required over 6 months. HPV is a high-prevalence sexually transmitted disease: In fact, about half of adult Americans who are sexually active will become infected at some time in their lives. Because the new vaccine is far less effective against already-established infections, immunization is plainly indicated for young girls before they become sexually active; and, after additional testing, probably for boys as well. Already, Merck and GSK are applying to market products in Europe and South America and are conducting additional trials to test for long-range efficacy and possible effects on pregnancy.


Scientific advice on immunization issues in the United States is the responsibility of the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention and various other units of the U.S. Public Health Service. On 29 June, that group met in Atlanta, recommended that females between the ages of 12 and 26 receive the vaccine, and suggested that it be made available for girls aged 9 and older on the advice of a physician. But major challenges remain in the wake of that decision. The first is to determine how it will be paid for. The total treatment costs for an immunization project of this magnitude would outrun the economic capacity of most cities and school systems, and of public health agencies in poor countries, where the needs are greatest.

The other problem, perhaps more serious, is that conservative religious groups in the United States, such as Focus on the Family, politically oppose a mandatory program on the grounds that it might encourage promiscuity. They deliver pro-forma praise for the vaccine (after all, who likes cancer?), but they then advise young women candidates that abstinence is a preferable alternative. That is bad advice.

If there is to be significant progress in reducing the incidence of cervical cancer, the HPV vaccine should be made part of a mandatory preschool immunization package. In the present situation, in which participation is voluntary, the girl who says no to vaccination and yes to Focus on the Family's advice to elect abstinence creates two risks. One is to herself: Numerous studies have shown that abstinence often fails; and even if it succeeds, it will eventually be displaced by either marriage or romance—with a partner who may have HPV. The second risk is to society: By declining vaccination, the refusenik becomes a free rider. The objective of vaccination programs is to reduce the overall probability of infection by creating herd immunity—that is, by making a large majority of the population immune. Those who won't participate in the vaccination program are thereby spreading a small risk to the rest of society. “Freedom of choice” is an argument favored by the abstinence advocates. But that slogan ignores a serious ethical consequence: If the choice entails spreading harm to other people, can it really be called “free”?

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