|
Panel Reviews New Vaccine That Could Be
Controversial
By GARDINER HARRIS
Published: October 27, 2004
http://www.nytimes.com/2004/10/27/health/27vaccine.html?oref=login&th
(must register to view original article)
A committee of experts meeting in Atlanta will debate today whether the
government can afford to pay for a vaccine that could save the lives of
nearly 3,000 people, many of them teenagers, from deaths caused over the
next decade by a virulent bacterial meningitis.
The price of the new vaccine will most likely be $80 a dose. Vaccinating
all 40 million people from age 11 to 20, as some experts have suggested,
would cost the government $3.5 billion next year. That is more than $1
million a life spared, far more than health officials are normally
willing to spend.
"How much would we have been willing to spend to save the victims of the
9/11 attacks, because that's the number of people we're talking about?"
asked Dr. Paul A. Offit, the chief of infectious diseases at Children's
Hospital of Philadelphia who is a committee member. "I believe it's
money well spent."
Dr. Jon S. Abramson, chairman of the pediatrics department at Wake
Forest University Medical School and another committee member, said the
government could not afford such a campaign.
The debate before the Advisory Committee on Immunization Practices is a
classic argument about how much the government should spend on
breakthrough technologies that spare life and prevent suffering.
Medicare officials frequently struggle with similar debates as they
decide whether to pay for expensive wonders like implantable
defibrillators or brain scans.
These debates were once unheard of among vaccine experts, because most
inoculations are far cheaper than the cost of treating the diseases they
prevent. As a result, the government buys and distributes more than half
of all vaccines.
That system is under strain. The latest vaccines are expensive, and the
diseases they affect are increasingly rare. For the first time, the
government has to decide whether such medicines are worth the cost.
Regardless of the panel's decision, people who can afford the new
vaccines will quite likely have access to them. Families relying on
Medicaid and other government programs, however, may not obtain the
vaccines.
Most parents of college students are sent letters by the colleges that
suggest that their children be vaccinated against bacterial meningitis.
Menomune, the vaccine currently sold to fight meningococcal meningitis,
provides protection only for a few years, and it is minimally effective
in young children. The new vaccine, Menactra, will be the first to
provide long-lasting immunity.
The debate occurs amid a flu vaccine shortage that has become one of the
worst vaccine-related crises in decades. The advisory committee, the
government's chief panel of vaccine experts, is scheduled to spend this
morning to discuss the flu crisis. The afternoon will be devoted to
Menactra, manufactured by Aventis Pasteur to prevent meningococcal
meningitis, a disease that can kill healthy teenagers within hours.
The committee will make a recommendation to the Centers for Disease
Control and Prevention, which will follow its advice after Menactra has
been licensed for sale by the Food and Drug Administration, which is
widely expected to occur soon.
Besides deciding whether to pay for Menactra, the committee also has to
figure out how to have children take the vaccine.
"We don't have a good track record immunizing adolescents," said Dr.
Lance Rodewald, director of the immunization services division of the
National Immunization Program at the disease centers.
Solving this riddle is crucial, because Menactra is generally expected
to be the first of a series of new vaccines intended for 11-year-olds.
The others include booster vaccines against tetanus, diphtheria and
whooping cough and vaccines against cervical cancer and herpes.
Frightening parents about the consequences of failing to vaccinate their
children will most likely be part of the campaign. For that task,
meningococcal meningitis is ideal.
"The disease is truly awful," Dr. Rodewald said.
Kathy Huddleston, 59, of Cedar Rapids, Iowa, had never heard of the
disease until last September, when she learned that her 20-year-old
daughter, Elizabeth, was dead at a hospital in Cedar Falls, Iowa.
Elizabeth, a junior at the University of Northern Iowa, awoke with what
she thought was the flu on Sept. 21. Elizabeth took a shower around
midafternoon and noticed a rash, Ms. Huddleston said. Around suppertime,
she began throwing up.
Her boyfriend took her to an emergency room, where doctors diagnosed the
flu and sent her home. At 5:30 the next morning, she started having
trouble breathing. She died before her boyfriend could return her to the
hospital.
The case is typical. By the time victims realize they are desperately
ill, it is often too late. Fever, nausea and flulike symptoms are often
followed by a rash, stiff neck, sensitivity to light and delirium.
Infections can be fatal within hours, although quick and aggressive use
of antibiotics cure most infections without permanent effects.
"It's one of the few remaining infectious diseases in America where
someone is healthy one day and dead the next," said Dr. Nancy Rosenstein
of the meningitis and special pathogens branch at the disease centers.
Meningococcal meningitis is one of three forms of meningitis caused by
ball-shape bacteria with slimy coats that are particularly tough for the
body's immune system to fight. Illness caused by the other bacteria like
haemophilus influenza type B and pneumococcus were once far more common,
but there are effective vaccines against the two.
The bacteria that cause meningococcal meningitis commonly live in the
human throat and nose. Why they sometimes invade the spinal fluid or
bloodstream is not understood.
Nearly 3,000 Americans a year are sickened. About 300 die, and 600 are
permanently scarred or disabled.
Whether Aventis could make enough vaccine for all teenagers is in doubt,
said Dr. Michael Decker, the company's vice president of scientific and
medical affairs.
Lynn Bozof of Marietta, Ga., said she would spend any amount to get back
her son Evan. Evan, a 20-year-old junior at Georgia Southwestern
University in Americus, died of meningitis after he began having what he
thought was a migraine.
"The government needs to find a way to pay for this and protect all of
our children," Ms. Bozof said.
|
