A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market

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By Rob Stein
Washington Post Staff Writer
Thursday, March 26, 2009

When a vaccine designed to protect girls against a sexually transmitted virus arrived three years ago, the debate centered on one question: Would the shots make young girls more likely to have sex?

Now the vaccine's maker is trying to get approval to sell the vaccine for boys, and the debate is focusing on something else entirely: Is it worth the money, and is it safe and effective enough?

"We are still more worried about the promiscuity of girls than the promiscuity of boys," said Susan M. Reverby, a professor of women's studies and medical history at Wellesley College. "There's still that double standard."

The shift in the discussion about Gardasil illustrates the complex interplay of political, economic, scientific, regulatory and social factors that increasingly influence decisions about new types of medical care. For the vaccine, the new dynamic reflects a strategic tack by Gardasil's critics, growing concern about health-care costs, fears about whether medical treatments are being vetted adequately and stubborn biases about gender, experts say.

"There is the cost, the safety, the boys versus girls," said Susan F. Wood, a professor of public health at George Washington University. "These are some of the complexities that are going to have to be addressed one way or the other with this vaccine."

Gardasil protects against the human papillomavirus, the most common sexually transmitted infection. HPV causes genital warts and, in women, can lead to cervical cancer -- a disease that strikes about 10,000 American women a year and kills about 3,700.

For males, the vaccine is aimed at protecting against genital warts and less common malignancies that HPV can cause, such as penile and anal cancer, as well as cancer of the mouth and throat. The virus causes at least 250,000 new cases of genital warts and an estimated 7,500 cancers in males each year, causing perhaps about 1,000 deaths. Vaccinating boys and men would also help prevent the spread of the virus to their sexual partners.

"By vaccinating men as well as women, you reduce the amount of virus that is out there that can be transmitted back and forth," said Richard M. Haupt, who leads the HPV vaccine program at Merck & Co., which makes Gardasil. "Hopefully there will be a benefit not only to men themselves, but to their partners and future partners."

After the Food and Drug Administration approved the vaccine in 2006 for girls as young as 9, medical authorities recommended that they receive it at age 11 or 12 to protect them before they start having sex. Critics worried that vaccinating children would send a subtle signal that their parents assumed they would become sexually active and that it would give youngsters a false sense of security.

Merck also began an ambitious marketing campaign and lobbying push to persuade states to add the vaccine to the list of those required for children to attend school. But the company eventually abandoned the strategy in the face of an intense backlash from critics who argued that the decision should be left to parents. Although many states considered such mandates, so far only Virginia and the District have imposed one, and Haupt said the company has no plans to pursue that strategy again.

But in December, Merck asked the FDA to approve the vaccine for males ages 9 to 26, and in February it presented the results of a large study that tested the vaccine in men to the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, in the hopes of winning the panel's endorsement. The committee's recommendations influence which vaccines schools require and whether private insurance companies and state programs will pay.

"There would be a tremendous public health benefit to vaccine 11- and 12-year-olds, both boys and girls," Haupt said.


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