NEW YORK — Just when Americans think they have nothing left to
worry about except overeating and obesity, along comes an influenza
epidemic that shows just how broken-down our public health systems
can be.
Three dozen people have already died in a flu epidemic that
promises to be one of the worst in recent memory. In Malad, Idaho,
2,000 people have taken sick and church services and Christmas
festivities have closed down. New York hospital emergency rooms are
jammed with sick children. About 36,000 Americans die annually of
flu complications.
This year’s total is likely to be much higher. “These viruses
are relatively mild strains,” says Jack Calfee, drug policy expert
at the American Enterprise Institute. “But if we hit a real killer
strain like we encountered in 1918, there wouldn’t be much we could
do about it.”
How did a country that worries itself to death over every little
environmental carcinogen and insists that every slice of processed
cheese be individually wrapped suddenly fall flat over such a
time-tested procedure as flu vaccinations?
The problem lies in the nature of our health concerns. Americans
are very good at avoiding “Type 1” accidents, where somebody does
something wrong and gets blamed for it. What we tend to ignore are
“Type 2” accidents, where somebody is prevented from doing
something and other people suffer the consequences.
WHEN “SWINE FLU” HIT IN 1975, President Gerald Ford called for a
massive government vaccination program. At the time there were
nearly 30 vaccine manufacturers in the United States. Leery of the
growing rash of medical malpractice, they declined to participate.
Every vaccine will produce an adverse reaction — even paralysis or
death — in a one or two out of a million or more people. With
malpractice awards running higher and higher, the liability
exposure was becoming unbearable.
So Congress set up a special fund to protect the manufacturers.
As Peter Huber documents in Liability: The Legal Revolution and
Its Consequences (1988), Congressional accountants predicted
with perfect precision the number of vaccines to be administered,
the number of adverse reactions that would occur, and the number of
lawsuits that would result. However, they underestimated the damage
awards by a factor of ten. Trial lawyers were much more
efficient at wringing damages out of juries than anyone had
anticipated.
Realizing the problem was endemic, Congress passed the National
Childhood Vaccine Injury Act of 1986, which established the
National Vaccine Injury Compensation Program (VICP). Like Worker’s
Compensation or the Federal September 11 Compensation Fund, VICP
compensates victims for medical and economic damages according to
fixed schedules. What is eliminated is non-economic “pain and
suffering” and “punitive damages” that ring up the legal
jackpots.
Lawyers are ingenious, however, and soon circumvented the law by
going after portions of the product that were “not essential to the
vaccine.” The most common target has been thimerosal, a
mercury-based compound that has been used to preserve vaccines from
spoliation since the 1930s. Based on the usual anecdotal evidence,
the drumbeat has begun that thimerosal is responsible for a
“national epidemic of autism.”
“Before the 1990s, 1 in 10,000 children were diagnosed with
autism. But in the past decade, as the government has increased the
number of mandatory vaccines, some recent studies suggest the rate
of autism has risen to 1 in about 250 children,” said one typically
breathless recent news report. “[Our news organization] has spent
the past three months investigating claims that government
regulators and some pharmaceutical companies knew of the dangers,
but never told the public.”
Based on such logic, you could also prove that thimerosal has
caused the rise in obesity or the decline in college-board scores.
Nonetheless, the government and manufacturers agreed to eliminate
thimerosal from children’s vaccines in 1999. Pending lawsuits have
convinced most drug companies that vaccines are a risky and losing
enterprise. Today only two companies remain — Wyeth and Chiron.
Glaxo, the largest vaccine maker in the world, sells flu vaccines
everywhere except in the United States. “Bringing our European
products to the U.S. would involve extensive clinical trials fore
the FDA,” says Danielle Halstrom, communications representative for
Glaxo. “That would be a significant investment.”
In 2002 the field shrunk even further when Wyeth dropped
FluShield, its adult product, and Pnu-Immune-23, its vaccine for
children. Instead, the company pursued Flu-Mist, a nasal spray that
finally won FDA approval last June. (The manufacturer, MedImmune,
is a wholly owned subsidiary of Wyeth.) Beyond that there is very
little research being done. “When you’re vaccinating 70 million
people each year, something bad is going to happen somewhere,” says
Calfee, of AEI.
Even without liability concerns, vaccines are an unrewarding
market. As with most preventive measures, people tend to wait until
they are threatened with the disease before buying. Last year the
two manufacturers made 95 million doses but only sold 83 million
during a mild flu season. The surplus 12 million doses had to be
destroyed. This year, just to be safe, they cut back to 85
million.
“Making vaccines is a very time-consuming process,” says Calfee.
“The decisions are made six to eight months in advance. Every
February officials from the Centers for Disease Control and the
manufacturers get together to evaluate what’s coming out of Hong
Kong and other parts of the world. Then they take a disabled strain
of the virus and grow it in chicken eggs. It’s not until June or
July that you have a product.”
After evaluating this year’s evidence, the committee decided to
go with protection against the “Panama” strain that was almost
identical with last year’s. A dark horse, however, was a new strain
just emerging out of the Fuji province of China. Under the
consensus system, both manufacturers went along with CDC’s choice
for the Panamanian strain. Now the Fujian strain has proved far
more virulent.
OUR FLU PROTECTION CURRENTLY resides in a system that is perilously
close to the old Soviet “planning” model. One big government
institution — the CDC — directs the decisions of two giant
manufacturers.
What is missing here is the capitalist dynamic. If there were a
dozen manufacturers operating independently, a couple would have
undoubtedly taken a chance with the Fujian strain. One might have
even bet the farm and produced an oversupply, taking the chance the
other manufacturers would be caught short. That gambler would have
made a fortune — and the country would have had enough
vaccines.
Instead, we have a lumbering bureaucracy whose main product is
platitudes. “We’re exploring all options,” said Tom Skinner,
spokesman for the CDC. “We need more research. It’s ridiculous to
be relying on chicken eggs. We need new manufacturing methods.” Did
he have anything specific in mind — something that’s been tried in
the laboratories or shown to work elsewhere?
“Not really,” he said.
