The New York Times | February 24, 2008
By Jan Hoffman

HOW cool are those Gardasil Girls? Riding horses, flinging softballs, bashing away on drum sets: on the television commercials, they are pugnacious and utterly winning. They want to be “One Less,” they chant — one less victim of cervical cancer. Get vaccinated with Gardasil, they urge their sisters. Protect yourselves against the human papillomavirus, or H.P.V., which causes cervical cancer.

But someone’s missing from this grrlpower tableau.

Ah, that would be Gardasil Boy.

Gardasil Girl’s cancer-related virus? Sexually transmitted. She almost certainly got it from him.

So far, Gardasil is approved just for girls. They can be vaccinated when they are as young as 9, although it’s recommended for 11- and 12-year-olds, before they are sexually active.

As the commercials show, the pitch to Gardasil Girl’s parents doesn’t need to address sex: it’s about protecting their daughter from a cancer.

By 2009, the vaccine could be approved for boys as well. Although Gardasil also protects against genital warts, which are not life-threatening, the primary reason to extend approval to boys would be to slow the rates of cervical cancer. Public health folks charmlessly call this “herd immunity.”

Will parents of sons consent to a three-shot regimen that has been marketed as benefiting girls? How do you pitch that to Gardasil Boy’s parents?

Think altruism. Responsibility. Chivalry, even? Oh, and yes: some explicit details about genital warts and sexual transmission.

Madeline Cattell, an interior design consultant in Beverly, Mass., and the mother of two boys, ages 8 and 12, never paid much attention to Gardasil, assuming it was a gender-specific vaccine for a gender-specific disease. She was surprised that her boys might be offered it one day.

“You don’t want to say it’s just the girls’ problem,” Mrs. Cattell said hesitantly. “But my sons won’t contract cervical cancer. And genital warts are treatable. I’m very skeptical. What risks will I expose them to?”

Gardasil got off to a rocky start. Approved by the Food and Drug Administration in 2006, for girls and young women, ages 9 to 26, it came under attack for its high cost. Conservative groups feared it would encourage promiscuity. But buoyed by recommendations by the Centers for Disease Control and Prevention, Merck has distributed 13 million doses in the United States alone; insurance picked up much of the tab. In 2007, worldwide sales of Gardasil brought in $1.5 billion.

Gardasil protects against four types of H.P.V. Two have been found in 70 percent of cervical cancer cases. The other two types account for 90 percent of genital warts, which affect both men and women. Immunization gives protection for five years.

Sometime this year, Merck will submit data to the F.D.A. seeking approval to give Gardasil to boys. In Australia, Mexico and countries in the European Union, the vaccine is approved for boys.

“We have a very clear benefit that we offer to men,” said Dr. Richard M. Haupt, Merck’s executive director of clinical research, referring to the warts, “even if they don’t feel they need to have an altruistic reason to get the vaccine.”

Of course, many parents will automatically dismiss Gardasil. They view Big Pharma in general and new vaccines in particular with suspicion. Barbara Goodstein, a Manhattan insurance executive, who has a daughter, 10, and a son, 12, plans to refuse the vaccine for both. “I wouldn’t give children that young a shot without multiple generations of research,” she said.

A competing vaccine, developed by GlaxoSmithKline to protect females between the ages of 10 and 55, is being reviewed by the F.D.A. The company is studying its vaccine, Cervarix, in boys as well as girls in Finland. Cervarix does not protect against genital warts. Boys are being included in the trial to see whether vaccinating them will help eradicate cervical cancer.

That’s good enough for some mothers. “If there was a vaccine I could take that would get rid of prostate cancer, why wouldn’t I?” said Lisa Lippman, a Manhattan real estate broker with three sons. “If there was a vaccine that sons could get that would get rid of breast cancer, most parents wouldn’t hesitate. But cervical cancer is the ‘sex cancer.’ ”

A few reports show that American parents generally favor the Big Idea that Gardasil be made available to both boys and girls. But few surveys discern whether parents would consider the vaccine specifically for their own sons. In 2003, Dr. Elyse Olshen Kharbanda interviewed Boston-area parents.

“They didn’t see it as having much benefit for their sons,” said Dr. Kharbanda, now an adolescent specialist at New York-Presbyterian/Columbia University Medical Center. “It was smart of Merck to get people excited about it for the girls, but now they’re stuck with that perception.”

Cervical cancer, which kills a quarter-million women a year worldwide, has long been a subject of urgent research. In the United States, about 3,700 women die from it each year; screenings like Pap smears have greatly lowered mortality rates here. But H.P.V. also causes a host of precancerous conditions: a study put the annual cost of cervical H.P.V.-related disease at $2.25 billion to $4.6 billion.

H.P.V. is the most common sexually transmitted infection. There are estimates of six million new infections in the United States each year. Yet, of more than 100 types of H.P.V., only a handful may result in disease. Most people who are infected have no symptoms and can transmit it unknowingly.

At least a half-million Americans each year develop genital warts, which can reoccur. But is Gardasil’s protection against warts enough for parents of sons?

“It’s not life-threatening, but it’s very stressful,” said Susan L. Rosenthal, a specialist in adolescent psychology at the University of Texas at Galveston and an adviser to Merck. “Genital warts are a really yucky disease and they make you feel bad about an important, sensitive body part. Psychologically, it’s not an insignificant infection.”

Baruch Fischhoff, a professor of decision sciences at Carnegie Mellon, thinks that older boys may see a mix of benefits in Gardasil. “Being able to say to a girl, casually, that you had the shots, boys might think, ‘If I can slip that into the conversation, it makes me less of a risk and seem like more of a humanitarian,’ ” Dr. Fischhoff said. “So the self-interested and altruistic motives could actually support each other.”

Some doctors even envisioned college kids, gay and straight, insisting partners get vaccinated.

Down the road, the vaccine may have other benefits. H.P.V. also causes anal and penile cancers, which are relatively rare, and some head and neck cancers.

The burden of explaining genital warts to fifth-grade boys and their parents, as well as spelling out how boys could give girls a virus that could lead to cancer, will largely fall on pediatricians.

Dr. Evelyn Hurvitz, a pediatrician in Tonawanda, N.Y., is beginning to map out those Gardasil discussions. “If you have an 11-year-old boy in your office,” she mused, “the last thing he’s thinking about is having sex with a girl. He’s still thinking about getting past talking to a girl.”

Tough sell.

“Then you have the parent of a 15-year-old boy who might be sexually active,” Dr. Hurvitz continued. “And so I would say, ‘This is a disease he could give to a loved one.’ And then I’ll hear, ‘But our son isn’t sexually active.’ And he’ll be squirming. So I’ll say, ‘Maybe not, but eventually he will be.’ ”

Dr. Hurvitz wishes that Gardasil had been available for boys and girls from the outset: “It would have been easier to get across the idea that this is a vaccine to prevent transmission of H.P.V.,” she said.

A few prescient pediatricians are already laying a foundation. The other day, during Cathy Anderson’s 11-year-old son’s annual check-up, the pediatrician mentioned that Gardasil might become available for boys.

“He talked about taking responsibility for controlling a communicable disease,” said Mrs. Anderson, a stay-at-home mother in West Lafayette, Ind. “My first reaction was: ‘Well, that makes sense.’ Then I told my son he wouldn’t have to worry about the disease, because he wouldn’t be having sex until he’d been married for a long time.”