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
esilverman@starledger.com.
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