A child is sick: high fever, acutely sensitive to light,
spots break out all over her body. Another child falls ill.
Suddenly hundreds are infected, and dozens are hospitalized.
Deaths are feared. Smallpox? Anthrax? A terrorist attack? Try
measles--in Germany--this past March. The same thing happened
one decade ago in the United States: 11,000 were hospitalized
and 123 died.
It could easily happen again. And not just with measles.
Currently the United States is experiencing shortages of eight
of the eleven vaccines required by law for children: measles,
mumps, rubella, diphtheria, tetanus, pertussis (whooping cough),
varicella (chicken pox), and pneumococcal disease (meningitis).
In response, the Centers for Disease Control (CDC) have revised
their immunization schedule from "optimal" to "some protection,"
which means that, depending on the vaccine, kids may get the
first shot and not the boosters that solidify immunity, or they
may not get the first shot at all until several months past the
recommended age. In response to the shortages, some states are
relaxing their demands that kids get vaccinated before they come
to school this September. In Oregon, for example,
seven-year-olds will be allowed to forgo chicken pox shots and
diphtheria/tetanus boosters; Texas is deferring the
diphtheria/tetanus booster shot required for all 14-year-olds.
Which is scary, because children aren't the only ones at risk:
Spotty vaccination cycles for diseases such as rubella and
chicken pox mean that children may grow to adulthood without
immunity, remaining at risk for diseases that cause many more
complications for adults and can have devastating effects for
pregnant women.
The pharmaceutical industry and the CDC promise to alleviate
the shortages by the end of this year. But America's national
vaccine supply is so "fragile"--according to several prominent
immunologists--that, even if they do, shortages will almost
surely return. "These shortages speak to a bigger problem, which
is that at some level there is a slight crumbling of
infrastructure," warns Dr. Paul Offit, an infectious disease
expert at Children's Hospital of Philadelphia. "It's only going
to get worse." Which is why the terrorism-addled federal
government, which this year plans to spend $640 million to build
stockpiles of the vaccine for smallpox--a disease that hasn't
killed anyone in 25 years--needs to start worrying about
something more mundane and perhaps more dangerous: a deadly
outbreak of measles.
Most people assume the diseases that ravaged millions in the
early twentieth century no longer affect American children. And
in good years, when American kids get their required vaccines on
schedule, that's true. In the 1950s nearly every American child
came down with measles by the time he or she was seven, and the
number of measles cases hovered around four million per year.
But with the introduction of a measles vaccine in 1963, that
number plummeted to a few hundred cases per year. The same is
true for diphtheria, a disease that claimed more than 15,000
lives annually before a vaccine was instituted in 1923; today
it's all but eradicated in the United States.
But not every country is so lucky. In Russia, for instance, a
mid-1990s diphtheria outbreak infected 80,000 people and left
2,000 dead. And people from Russia, Germany, China, Britain, and
other countries where vaccination is less routine enter the
United States in large numbers every day. When the United States
keeps its vaccine levels above roughly 90 percent, according to
immunologists, that's not a big problem because of "herd
immunity." Thanks to herd immunity, immigrants who aren't
vaccinated--or for that matter native-born Americans who aren't
vaccinated--ride on the backs of the rest of the population and
are protected. A child or adult who is ill arrives in Seattle,
walks into a Starbucks, a grocery store, a movie theater. But
because pretty much everyone in those public spaces has been
vaccinated, the disease runs its course through that one person,
infecting perhaps the one other nonimmunized person the carrier
comes across, rather than being passed on to nearly everyone he
meets. The key is keeping vaccine levels up: If they fall below
90 percent, preventable diseases begin finding the chinks in our
immunization armor and sweeping through the population.
America's early '90s measles outbreak, for instance, started
among undocumented immigrant children in Texas and California
and the urban poor in Philadelphia and Chicago--where large
numbers of children were undervaccinated or not vaccinated at
all. But it quickly spread beyond those populations, affecting
even children in states with higher vaccination levels.
So what's causing the vaccine shortages that threaten our
herd immunity today? The answer begins and ends with our
peculiar quasi-free-market approach to producing vaccines.
Though undoubtedly a public utility, vaccines are manufactured
exclusively by independent pharmaceutical companies. This isn't
in and of itself a bad thing: Privatesector independence often
breeds innovation. The problem is that the incentive for such
innovation is profit. And unlike blockbuster drugs that lower
cholesterol or reduce anxiety, vaccines are notoriously
unprofitable.
For one thing, they are difficult to create: They often
require handling live viruses, and some take nearly one year to
produce. What's more, the Food and Drug Administration (FDA) has
recently clamped down on the manufacture of vaccines, requiring
pharmaceutical companies to make multimillion-dollar
quality-control upgrades to their production facilities in order
to comply with what's called "good manufacturing practice" and
to ensure uniform safety standards. The FDA also recently
decided that vaccines could no longer be preserved in a solution
called thimerosal, a mercury-based concoction long used in
multidose vials of certain vaccines. Companies whose vaccines
were sitting in thimerosal had to switch from multi- to
single-dose vials--a transfer that immediately reduced supplies
by 25 percent--as single-dose vials must be overfilled to allow
syringes to withdraw the appropriate amount.
And once the vaccines get to market, they don't fetch top
dollar. Some 50 percent to 60 percent of vaccines are bought by
the government, which typically purchases them at near cost.
"The trend [is] to shoot for the lowest possible price whenever
there's a negotiation between government--which is the country's
largest purchaser--and the industry," says Dr. Tom Zink, a
representative of pharma giant GlaxoSmithKline. The other 40
percent of the vaccine market--covered primarily by
private-sector health insurance and out of pocket by the
underinsured--doesn't help much either because Americans, most
of whom don't remember the tragedy of diseases like diphtheria,
generally chafe at paying high costs for vaccines. As Offit
notes, many people balk at spending $10 for an influenza
vaccine, though it would cost more than ten times that amount to
treat the illness itself. And even for those vaccines that do
cost more--like the new meningitis vaccine, which costs $250 for
a five-course dose--the cost is only paid once per patient.
Compare that to pricey drugs like cholesterol-lowering Lipitor
that are taken daily for years.
As a result of these economic disincentives (combined with
various lawsuits that scared off several pharmaceutical-industry
players), over the last 20 years the number of companies
producing vaccines has dropped from 15 to four. And there is
little overlap in production between the remaining four, which
means stockpiles are often minimal or nonexistent. In December
2001, for instance, a company called Wyeth Lederle decided to
stop producing the DTaP (diphtheria/tetanus/pertussis) vaccine
with only one month's notice. That left Aventis Pasteur as the
only company still marketing the tetanus vaccine in the United
States. And Aventis didn't have enough supply to make up for the
loss. The result was, and remains, that the tetanus vaccine is
unavailable almost anywhere in the country except emergency
rooms.
The irony, as Dr. Louis Cooper, president of the American
Academy of Pediatrics, points out, is that "immunizations are
the most cost-beneficial medical invention in history." Next to
purifying the water supply, nothing has been as "profoundly
effective" in improving public health at such a low cost. "What
we have to do," says Cooper, "is take a step back and look at
how we align incentives.... Because drug companies are not
philanthropies. If you were a CEO of a drug company and you
looked at your portfolio, do you invest in a vaccine or a
hypertensive or an anti-anxiety or anti-pain medication? Where
is the return on investment quicker and profoundly more?"
One option--proposed by the Institute of Medicine (IOM), a
nonprofit research arm of the National Academy of Sciences--is a
National Vaccine Authority (NVA), a public-private partnership
charged with overseeing immunizations across the country. With
the NVA, says IOM president Dr. Kenneth Shine, "government
involvement would only occur when the market is not meeting
demands." He suggests the creation of a government-owned
facility or a contract between private industry and the
government, like the one the Department of Defense has set up to
create vaccines for bioterrorism.
Industry, not surprisingly, balks at establishing another
bureaucratic agency. And not without reason. In fact, something
like the NVA already exists; it's called the National Vaccine
Program (NVP), a congressionally mandated bureaucracy set up to
coordinate the efforts of various federal agencies involved in
vaccinations. Rather than starting from scratch, the NVP could
be significantly strengthened. An important first step would
simply be improving the currently poor state of communication
between the various agencies and corporations that comprise the
NVP. "Close, tight communication between industry, the
Department of Health and Human Services, the CDC, [and] the FDA
on issues relating to vaccines" is imperative, says Lance
Rodewald, director of the Immunization Services Division at the
CDC. Manufacturers, suggests Rodewald, might be required to
notify the government further in advance when they plan to stop
making vaccines so other companies have time to ramp up
production.
A stronger NVP could also press the FDA to work with
international drug manufacturers in an effort to "harmonize
requirements across countries." If production standards were
harmonized across borders, the United States could import
vaccines to alleviate supply shortages, which it can't easily do
today. The NVP could also do a better job of tracking current
stockpiles and encouraging the creation of additional stores.
Because many vaccines expire if left to sit like computer paper
on a shelf, they must be cycled through and distributed to keep
the stash on hand as fresh as possible. The NVP could make sure
that both manufacturers and the federal government keep their
supplies current and plentiful.
Of course, all this will take more money from Congress. And
so far Congress hasn't been particularly interested in handing
it over. Two years ago the Institute of Medicine recommended $75
million in additional funding for the NVP; but Congress
appropriated only $42.5 million. Fortunately, the General
Accounting Office is due to issue a report at the end of July
examining the vaccine shortages, which will hopefully prompt
Congress to take the issue more seriously.
But in the meantime, children across the country are being
sent home from their pediatricians without the shots they
require. "[A]ny underimmunized child anywhere in the country
puts the rest of the country at risk," Dr. Walter Orenstein,
director of the National Immunization Program at the CDC, has
said. The more kids don't get their immunizations, the more
likely long-forgotten diseases like measles will return to
afflict Americans. Which would be shameful, because this form of
bioterrorism is entirely preventable.
