January
17, 2003 -- IOM report on smallpox vaccination released
The
requested by Center for Disease Control, was released this afternoon.
The 52 page document validates many of the safety,
compensation, and
other issues brought up by unions, healthworkers, and the public. The
government has already said it is going ahead with its plans
unchanged.
Interestingly, much of the IOM report dealt with how CDC and health
officials in the vaccination program should communicate with the
public. On one hand, they say, public health must speak with a
separate voice from political or military figures to maintain
credibility. On the other hand, public health must communicate the
fact that the pre-outbreak vaccination campaign "is neither a
research study nor an ideal public health program. Rather, it is a
public health component of bioterrorism preparedness." Both of these
points are emphasized a number of times. (Excerpts below.)
The government insists that the impending
like it, increase the public's risk of terrorist
retaliation. If this
is true, why is the government continuing the invasion, placing the
public in harms way, and enmeshing public health with military
adventure? What choice do healthworkers have but to resist the war?
Panel Recommends Slow Smallpox Approach
By LAURA MECKLER, Associated Press Writer
WASHINGTON - Federal officials prepared to ship smallpox vaccine to
about a dozen states as a scientific advisory panel urged them to move
cautiously. The panel said reactions to the first round of
inoculations should be analyzed before giving shots to
millions of
health care and emergency workers.
The scientists also recommended that health workers being
offered the
vaccine be told that it carries real risks, and that they are likely
to receive only minimal compensation if they are injured.
"The committee suggests explicitly stating that the benefit of the
vaccination program is to increase the nation's public health
preparedness, but that the benefit of vaccination to any one
individual might be very low," the panel convened by the
The last case of smallpox in the
ago. Routine vaccinations here ceased in 1972, but experts fear the
disease could return in an act of bioterror.
Still, the risk of such an attack is unknown, and the chances that any
given person will encounter the virus are particularly small, the
well documented: Based on historical information, as many as 40 people
out of every million being vaccinated for the first time will face
life-threatening reactions, and one or two will die.
A plan announced last month by President Bush (news - web sites) calls
for quickly vaccinating nearly a half million people working in
hospital emergency rooms and on special smallpox response teams, with
inoculations set to begin next Friday. With little time remaining, the
panel recommended a series of safeguards aimed at educating people who
may receive the vaccine, tracking their reactions to it and
communicating with the public about the smallpox program.
Officials at the Centers for Disease Control and Prevention (news -
web sites) said they were confident that people offered the vaccine
would be given the information they need and that they
would carefully
track reactions.
"Protecting the public is our core business and it's certainly our
highest priority," said Dr. Julie Gerberding, CDC director.
Chiefly, the committee said, people being offered the shot must
understand that they are helping to prepare the nation should
bioterrorism strike - unlike other vaccines which
primarily protect
the person getting the shot.
The experts also recommended that people be specifically told that
they may not receive any compensation if they are injured by the
vaccine.
Congress acted to protect people and institutions delivering the
vaccine from most lawsuits that could be filed by
those injured by the
inoculation, leaving such patients with little recourse. Under the
policy, injured people may have access to state workers' compensation
programs, but those programs are not likely to cover all medical
expenses and time lost from work.
An existing compensation fund helps people injured by other vaccines,
but it does not cover smallpox. So far, the administration has not
proposed any similar fund for smallpox.
Without a way to reimburse people for their lost work time and medical
expenses, the panel said, "some, perhaps many" people may decline to
get vaccinated, undermining the effectiveness of the
program.
Gerberding said the administration is working on the problem but
didn't have a solution yet. In the meantime, she said,
"we are
certainly not going to delay this program because of concerns about
compensation."
Similar concerns were voiced Friday from Capitol Hill.
Several
Democrats, including House Minority Leader Nancy Pelosi, called on
Bush to create a compensation fund for people injured by the vaccine,
saying it was "manifestly unjust" to deny help for health care
workers
who are hurt because they stepped up to help the nation prepare for a
bioterror attack.
The first phase of the program is set to begin next Friday, and
Gerberding said CDC planned to ship more than 50,000 doses of vaccine
to 11 states on Tuesday, as of Friday afternoon. She would not name
them, but officials in
Hampshire
The
slowly to the program's second phase, when the vaccine will
be offered
to some 10 million people, including other health care workers and
emergency responders such as police and firefighters.
Friday's report recommended that the CDC evaluate the rate of serious
reactions, the effectiveness of its educational material and the
variation in vaccination policies from round one before moving to the
second group of vaccines. It said the CDC also needs a more aggressive
monitoring system to track reactions to the vaccine.
The CDC also should name a "single voice" to communicate with the
public - someone with a strong scientific background and widely
recognized credibility, the panel said. That person, the panel added,
"should not be a politician."
During the 2001 anthrax attacks, the Bush administration was
roundly
criticized for inaccurate information given by politicians. Many say
that the situation improved markedly after scientific experts took the
lead in communicating with the public.
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The full report is available at
http://www.nap.edu/html/smallpox_vac/ltr_report.pdf
Excerpts from the IOM report:
Having spoken of the risks of the vaccine, the report says, "This
precautionary program is a public health component of national
bioterrorism preparedness, and those who assume the vaccine's risks
may have a small likelihood of individually benefiting from it."
"The benefit of the vaccine is also unknown at this time. There is no
reason to believe that the efficacy of the vaccine at preventing
smallpox infection has changed, both in its protection of individual
vaccinees, and the additional protection it offers to others by
blocking smallpox transmission to the unvaccinated, although there is
no way to ascertain whether the vaccine would be effective against
bioengineered smallpox. However, the assumed benefit of the vaccine
includes an estimate of the risk of encountering smallpox virus; this
estimate was derived by the President and his advisors with a view to
national security issues .facts and considerations not communicated to
the committee. Based on the administration's statement that the risk
of a smallpox attack is indeterminate (not zero but currently assumed
to be very low) (White House, 2002), the benefit of the vaccination
program to the public also is not zero but is assumed to be
very low.
The benefit to any individual might indeed be zero if the individual
never encounters the smallpox virus. However, in the event of exposure
to smallpox virus, the benefit to individuals may be very high. Given
this profile of high vaccination risk and likely very low to zero
benefit, the administration's policy to offer vaccination to public
health, medical, and emergency workers must be implemented in a most
prudent and cautious manner. In general, public health interventions
are undertaken with recognition of some benefit to some individuals,
no effect on others, and the possibility of some risk to a small
percentage of the population (e.g., folic acid supplementation of the
food supply), with expectation of overall benefit to the population
receiving the intervention."
"It is standard practice to request consent to an intervention, such
as vaccination, but highly unusual for an intervention, other than in
clinical trials, to have known risks but unknown benefits. Yet, that
is the nature of this program, within the broader context of national
security. The committee suggests explicitly stating that the benefit
of the vaccination program is to increase the nation's public health
preparedness, but that the benefit of vaccination to any one
individual might be very low (given the current threat assessment).
Vaccinees must have a clear understanding of the real risks of the
vaccine and of the consequences of developing smallpox, tempered by
the best estimate of the risk of a smallpox release."
"Also, the committee recommends that CDC's
communication efforts about
smallpox vaccination clearly separate public health issues from
national security matters. The latter are best addressed
by
representatives of the administration more directly involved in such
matters, and not by representatives of scientific agencies. Therefore,
the responsibility of CDC is to deliver clear, consistent, and
science-based public health communications."