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"Protecting the health and informed consent rights of children since
1982."
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The
Scientist 16[2]:64, Jan. 21, 2002 |
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OPINION
A Smallpox Shot in the Dark
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By
Henry I. Miller
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Sixty
percent of Americans would opt for smallpox immunization if the vaccine were
available, according to a recent poll, and U.S. health officials
have just negotiated the purchase of enough vaccine for everyone in the United
States. Those two facts may be a prescription for bad medicine.
Medically and epidemiologically, smallpox is
the most feared and potentially devastating of all infectious agents. It
spreads from person to person, primarily via droplets coughed up by infected
persons, via direct contact, and from contaminated clothing and bed linens.
Smallpox is fatal in approximately a third of previously unvaccinated persons
who contract the disease.
For weeks, the media have raised the specter
of terrorists using smallpox virus as a weapon. The German government has
bought six million doses of vaccine, and pressure is mounting in the United
States for widespread, or even universal, vaccination. (Routine smallpox
vaccinations ceased in this country in 1972.) The U.S. government has ordered
300 million doses of the vaccine, and at a recent hearing, U.S. Sen. Arlen
Specter (R-Pa.) said it is just "common sense" to make it available
to everyone who wants it.
But is it really? The live vaccine consists
of live vaccinia virus, which is closely related to smallpox virus. Impure and
crude by the modern standards of recombinant DNA-derived, or gene-spliced,
vaccines such as those that have been successfully deployed against hepatitis B
since the 1980s, the smallpox vaccine is not very different from the one
introduced by the English physician Edward Jenner in the 18th century. It can
provoke various serious side effects, including rashes; spreading from the
inoculation site to face, eyelid, mouth or genitalia; and generalized
infection. Approximately one in every 300,000 vaccinations causes encephalitis,
which can lead to permanent neurological damage; and between one and three in
every million die. Thus, vaccinating the entire population would be expected to
kill as many as a thousand Americans, and maim and disfigure many others.
Moreover, that assumes that the newer, ostensibly incrementally improved
versions of the vaccinia vaccine are no less safe: Federal regulators have been
uncharacteristically lax about requiring evidence of safety and efficacy in a
drug intended for healthy individuals.
If the re-emergence of smallpox were likely,
vaccination would be appropriate. However, smallpox virus no longer occurs in
nature but is limited to two known, legitimate repositories, one in the United
States, the other in Russia (and perhaps to illegitimate ones in several other
countries). It is, therefore, very difficult to obtain, and also to cultivate
and disseminate.
Also, smallpox is not immediately contagious
after infection. It can be transmitted from one person to another only after a
one- to two-week incubation period and the appearance of the characteristic
rash, by which time the victim is prostrate, bedridden, and probably
hospitalized. Therefore, the much-publicized scenario in which suicide
terrorists infect themselves and then spread the disease widely through the
population is not a realistic one. And although universal smallpox vaccination
was phased out throughout the world during the 1970s, individuals who were
vaccinated prior to that time retain significant immunity from these
immunizations, both against contracting the disease and against a fatal outcome
in case of infection. Scientists know a great deal about the long-term
retention of immunity from a landmark study of 1163 smallpox cases in Liverpool
in 1902-1903. Among those infected, 7% of the people 50 or older who had
received the vaccine as children experienced severe disease and death, while
26% of unvaccinated people in that age group contracted serious cases of
smallpox and all died.
Even if an outbreak were to occur, public
health authorities know how to respond. Control depends on early detection,
quarantine of infected individuals, surveillance of contacts, and focused,
aggressive vaccination of all possible contacts—an approach dubbed
"quarantine-ring vaccination." Approximately 15 million doses of
smallpox vaccine are available in the United States, and data suggest that
these would still be effective if diluted fivefold, to yield 75 million.
Moreover, the federal government has taken
steps to cope with the possibility of a terrorist attack involving smallpox by
educating doctors to recognize the disease and by vaccinating small teams of
experts who can rush to any part of the country to confirm the diagnosis and
contain and treat an outbreak. The city of New York has begun to map out various
locations where residents would go to be immunized should mass vaccinations be
necessary.
In summary, given the difficulty of
estimating the risks and benefits of vaccinating against a nonexistent disease
using a vaccine that carries known, serious, sometimes-lethal side effects, one
must agree with the conclusion of David Busch, head of infectious diseases at
California Pacific Medical Center in San Francisco. "It's
inappropriate" to vaccinate the entire country for a disease whose threat
is only theoretical, and immunization should only be given "as needed, not
as desired."
If federal officials act otherwise, they will
be more in the realm of public relations than public health. Even the
expenditure of upwards of a billion dollars to stockpile 300 million doses of
smallpox vaccine is arguably in the category of political cover. Far better,
surely, to use those resources to ensure that susceptible Americans are
immunized against common and life-threatening infectious diseases such as
influenza, hepatitis, and pneumococcal pneumonia. (Flu alone kills 20,000 in an
average year.)
Sherlock Holmes admonished in A Scandal in
Bohemia that "it is a capital mistake to theorize before one has
data." It is worse to make the wrong decision after one has data.
Henry
I. Miller (miller@hoover.stanford.edu),
MD, is a fellow at the Hoover Institution and the author of (Hoover Institution Press).
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