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PUBLIC HEALTH & EDUCATION | Gardasil Debate Shifts as Merck Pushes for Use in Boys, Men

PUBLIC HEALTH & EDUCATION | Gardasil Debate Shifts as Merck Pushes for Use in Boys, Men
[March 26, 2009]

Merck's request for FDA approval of its human papillomavirus vaccine, Gardasil, for use in boys and young men has refocused debate over the vaccine on cost-effectiveness and safety, a shift from earlier criticisms that its use in girls and young women could condone promiscuity, the Washington Post reports. According to the Post, the shift in the discussion "illustrates the complex interplay of political, economic, scientific, regulatory and social factors that increasingly influence decisions about new types of medical care." Experts say the change also "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," the Post reports. Susan Reverby, a professor of women's studies and medical history at Wellesley College, said, "We are still more worried about the promiscuity of girls than the promiscuity of boys. There is still that double standard." Susan Wood, a professor of public health at George Washington University, said that issues like "the cost, the safety, the boys versus girls" are "some of the complexities that are going to have to be addressed one way or the other with this vaccine."

HPV, the most common sexually transmitted infection, can cause genital warts and cervical cancer in women. Among U.S. women, the disease is diagnosed in about 10,000 individuals and kills about 3,700 annually, according to the Post. FDA approved the vaccine in 2006 for use in girls ages nine and older, and medical authorities recommend that girls receive it at age 11 or 12, before they start having sex. Critics have argued that vaccinating girls "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," the Post reports.

In men, Gardasil aims to protect against genital warts and less common diseases -- such as penile, anal, throat and mouth cancers -- that HPV can cause. Each year, HPV causes about 7,500 cancers, about 1,000 cancer deaths and at least 250,000 new cases in men. Merck in December 2008 requested FDA approval of Gardasil for boys and men ages nine to 26, and in February the company presented the Centers for Disease Control and Preventions' Advisory Committee on Immunization Practices with results of a large study that tested the vaccine in boys and men. The study, which involved more than 4,000 boys and men ages 16 to 23, found that the vaccine was about 90% effective in preventing infection with four types of HPV, as well as precancerous lesions and genital warts.

The Post reports that vaccinating boys and young men against the virus could prevent its transmission to their sexual partners. Richard Haupt, head of the HPV vaccine program at Merck, said that vaccinating both men and women would "reduce the amount of the virus that is out there that can be transmitted back and forth." He said, "Hopefully there will be a benefit not only to men themselves, but to their partners and future partners." Haupt added that there would be "a tremendous public health benefit" to vaccinating boys and girls at age 11 or 12.

According to the Post, the discussion on approving Gardasil for boys and men focuses on the cost effectiveness of the vaccine -- which costs about $500 for three shots -- rather than the public health benefits. The CDC committee will meet again in June to examine cost-benefit analyses regarding the vaccine. Laurie Markowitz, head of the HPV vaccine working group at CDC, said the data "will be looked at very carefully," adding that there is "increased interest in taking cost-effectiveness into consideration when considering prevention efforts." CDC could vote on the matter as soon as October. The Post reports that the American Academy of Pediatrics also will take cost-effectiveness into consideration when it decides whether to endorse Gardasil for boys and men.

The Post reports that some experts "question" the focus on cost effectiveness. Gregory Zimet, a professor of pediatrics and psychology at Indiana University, said that although the cost-effectiveness studies are "really important," he does not believe they should be the "sole driver of public health policy." He said Gardasil "principally benefits women's health," adding, "I wonder if it was the reverse, and there was a vaccine for women that helped prevent prostate cancer in men, this would be as much of an issue." Some experts also are concerned there is not enough evidence about how long Gardasil's protection will last, if serious side effects will emerge or if the "relatively modest benefits" for males are worth the small risks associated with all vaccines, the Post reports. Karen Smith-McCune of the University of California-San Francisco said there are "a lot of things about this vaccine we do not know yet." Diane Harper, a professor of medicine at the University of Missouri-Kansas City who helped Merck study Gardasil in women, said there is "probably enough data to say it probably is effective for the prevention of genital warts," adding that warts are "not fun, but they're not at the same level as cancer or lethal infectious diseases." Harper also said, "This may not be the best use of our resources at this time."

According to the Post, several experts say it might be harder to sell parents on Gardasil vaccinations for boys than for girls. Zimet said, "For girls, you can go right to the protection against cervical cancer. That's a powerful argument." He added, "For boys, you have to make several arguments. Part of it is an altruistic argument. I think it's persuasive, but it's more complex" (Stein, Washington Post, 3/26).

Study Shows Male Circumcision Can Reduce Risk of HPV, Herpes

In related news, a study published this week in the New England Journal of Medicine found that male circumcision can reduce a man's risk of contracting HPV and herpes, the Wall Street Journal reports. The new research "adds to the growing scientific evidence that the procedure helps stem the spread of some" STIs, according to the Journal. The new study -- conducted by researchers from Johns Hopkins University and Makerere University in Uganda -- used data from earlier trials about male circumcision and HIV in Africa that showed that the procedure can reduce a man's risk of contracting HIV through heterosexual sex. The new study found that circumcised men were 35% less likely to contract HPV compared with uncircumcised men. The circumcised men also were 25% less likely to contract herpes (Shishkin, Wall Street Journal, 3/25). The study found no effect on the transmission of syphilis. The researchers accounted for condom use, the number of sex partners and additional factors when calculating the men's STI risk. According to the researchers, male circumcision should become an accepted method to help reduce the risk of STIs from heterosexual sex among men, the AP/ reports (Chang, AP/, 3/25).