At first blush, a vaccine that prevents a deadly form of cancer would seem like a no-brainer for parents.
But as two major drug makers prepare to introduce such a product, sides are already being drawn in what promises to be an all-out culture clash.
Within two years, Merck and GlaxoSmithKline hope to market a pair of groundbreaking vaccines to prevent a sexually transmitted disease. Known as the human papillomavirus, or HPV, the disease is a leading cause of cervical cancer.
About 5,000 women in the United States die each year from cervical cancer, and the drug makers expect to use this as a rallying cry to make their vaccines widely available and generate billions of dollars in sales.
One drug maker, Merck, says it will try to convince states to require vaccination before children as young as 12 can enter school.
"The best way to prevent infection is to vaccinate the population just before they become sexually active, which is when they're young," Eliav Barr, Merck's senior director of biologics clinical research, said. "This way, it can be folded into routine medical care."
But the rollout of the vaccines promises to be anything but routine. Vaccinating children for a disease caused by sexual activity will be a tough sell, especially for parents who fear children will take it as a green light to have sex.
The HPV vaccine is likely to become a flashpoint for the pharmaceutical industry, public health officials and parents, who are gearing up for a heated debate about the finer points of cancer prevention, health-care costs and teenage sex.
The vaccines are still in the final stages of testing, but some groups are already concerned.
"The best way to prevent HPV is through abstinence," said Bridget Maher, an analyst at the Family Research Council, a conservative group that expects to campaign against making the vaccines mandatory for entering school. "I see potential harm in giving this vaccine to young women."
She isn't alone.
A Merck study of 2,053 parents released last year found 11 percent of parents with 13-year-old girls probably or definitely wouldn't want them vaccinated before their 18th birthday. Another 27 percent were undecided.
A separate study last year in the Journal of Lower Genital Tract Disease found 24 percent of 575 parents opposed a vaccine and believed it would lead children to engage in sexual activity sooner than they would otherwise.
At the same time, though, these studies suggest most parents do support vaccinating their children. The results also indicate some parents become supportive after learning about the health benefits or hearing doctors recommend vaccination.
Some doctors believe parents may become more supportive when they learn HPV can be transmitted through sexual contact, and not necessarily intercourse, according to a study in the American Journal of Epidemiology.
"This will be an arduous educational mission," said Daron Ferris, a professor of family medicine and obstetrics/gynecology at the Medical College of Georgia, who also ran trials for the Merck vaccine. "But once they realize we have a vaccine to prevent cancer, I'd expect parents will want to protect their loved ones."
Convincing parents may be harder for Merck than Glaxo, a British drug maker.
Unlike Glaxo, Merck will also target genital warts with its vaccine. Doctors caution this may fuel more controversy if teenagers see a vaccine as an easy way to combat yet another increasingly common sexually transmitted disease.
This is why some experts see trouble ahead. They point to the heated battle concerning an over-the-counter, morning-after pill a federal panel in 2003 recommended for girls as young as 16. Anti-abortion groups opposed the contraceptive pill, and the Food and Drug Administration has still not approved it.
"Sex is a scary thing in this culture, and the age of the girls to be vaccinated will really be an issue," said Janice Irvine, a University of Massachusetts sociology professor and author of "Talk About Sex," a book on sex education. "You can expect opposition to this vaccine."
These predictions worry the drug makers. As some best-selling drugs face competition from cheap generic rivals, vaccines will become a source of much-needed revenue. This is especially true for Merck. The Whitehouse Station-based drug maker next year loses patent protection on its cash cow, the Zocor cholesterol pill.
As Wall Street sees it, an HPV vaccine holds tremendous promise.
The global market could hit $4.3 billion in revenue by 2010, according to a recent report by Richard Evans, an analyst at Sanford C. Bernstein. His projection anticipates adolescent girls and boys, as well as women in their 20s and 30s, will be vaccinated.
The heady forecasts stem from data showing cervical cancer is widespread: About 500,000 women worldwide are diagnosed each year, leading to 230,000 deaths, according to the World Health Organization. In the United States, about 15,000 women are diagnosed annually.
For the companies to realize the billions of dollars in annual revenue, they are expected to advertise widely and charge alot. Merck will likely charge $100 for each of three needed doses, Evans said, while Glaxo may place an $80 price tag on each dose.
At those prices, an HPV vaccine would cost more than other childhood vaccines, according to an article in Clinical Infectious Diseases, which was written by officials at the Centers for Disease Control and Prevention.
An average dose of vaccine for measles, mumps and rubella cost $34.73 in 2003, while a dose of chickenpox vaccine was $58.11.
The HPV vaccines would be "fairly expensive for this country," said Lauri Markowitz, chief of epidemiology research in prevention of sexually transmitted diseases at the CDC, which believes a vaccine would help prevent cervical cancer.
An official CDC endorsement would not only influence doctors to recommend vaccination, but health plans would also be spurred to cover the cost.
The drug makers are unwilling to discuss prices, but note diagnosing and treating HPV is expensive. Related health costs were estimated to be at least $1.6 billion annually, according to a 1999 CDC study. The costs include doctor visits, Pap tests to detect cervical cancer and follow-up procedures.
"A vaccine would be a more efficient use of health-care dollars," said Evan Myers, an associate professor of obstetrics and gynecology at Duke University and a consultant to Merck, who has studied the economic impact of an HPV vaccine.
The best way to maximize savings, the companies maintained, is to vaccinate children as young as possible. Glaxo plans to push for vaccinating girls as young as 10, according to David Pernock, senior vice president for pharmaceuticals and vaccines.
"Anyone who thinks alot of teenagers aren't sexually active has their head in the sand," said Cody Meissner, a pediatrics professor at Tufts New England Medical Center and vice chair of the American Academy of Pediatrics' infectious disease committee.
"No one's pleased about that, but it's a fact of life. And if the results of the final-stage clinical trials for these vaccines are consistent with what's known so far, they will be a wonderful contribution to public health."
But convincing doctors may prove much easier than swaying state officials to require vaccination before youngsters can attend school, as Merck intends to do. The potential for controversy is so great that one New Jersey health official said he does not want to get involved.
"I don't think we'd require the schools to mandate something like this," said Eddy Bresnitz, deputy commissioner of the state Department of Health and Senior Services. "I'm sure the battle will be huge, and I'm not sure it's a battle we should be fighting."
Ed Silverman can be reached at (973) 392-1542 or .
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