Parents Balk at Idea of STD Vaccine for Kids
BY ED SILVERMAN
c.2005 Newhouse News Service
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.
One drug maker, Merck & Co. Inc., says it will try to persuade states to require vaccination of children as young as 12 before they're allowed to start the next year of school.
"The best way to prevent infection is to vaccinate the population just before they become sexually active, which is when they're young," said Eliav Barr, Merck's senior director of biologics clinical research. "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 may be a tough sell, especially among parents who fear children will take it as a green light to have sex.
Public health officials and parents are gearing up for a heated debate about the finer points of cancer prevention, health care costs and teenage sex.
"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."
A Merck study of 2,053 parents released last year found 11 percent of those 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.
The studies found most parents support vaccinating their children. The results also indicate some parents become supportive after learning about the health benefits or hearing doctors recommend vaccination.
HPV can be transmitted through other forms of sexual contact in addition to intercourse. As parents inclined to oppose vaccination learn this, they may become more supportive, 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 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."
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.
Some experts who see trouble ahead cite the heated battle concerning an over-the-counter morning-after pill recommended for girls as young as 16 by a federal panel in 2003. Anti-abortion groups opposed the contraceptive pill, and the Food and Drug Administration still hasn't 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."
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 those billions of dollars in annual revenue, they are expected to advertise widely and charge a lot, Evans said. Merck will likely charge $100 for each of three needed doses, he said, while Glaxo may charge $80 per dose.
The drug makers are unwilling to discuss prices, but note that diagnosing and treating HPV is expensive. Related health costs were estimated to be at least $1.6 billion annually, according to a 1999 federal 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 maintain, is to vaccinate children as young as possible. London-based GlaxoSmithKline plc plans to push for vaccinating girls as young as 10, according to David Pernock, senior vice president for pharmaceuticals and vaccines.
"Anyone who thinks a lot of teenagers aren't sexually active has their head in the sand," said Cody Meissner, a pediatrics professor at Tufts-New England Medical Center in Boston 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," Meissner said. "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 easier than persuading state officials to require vaccination, as Merck intends to do.
"I don't think we'd require the schools to mandate something like this," said Eddy Bresnitz, deputy commissioner of New Jersey's 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."
April 8, 2005