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Since President Bush announced the
national smallpox vaccination
program on Dec. 13, some 440,000 frontline healthcare and emergency
workers are faced with the decision of whether to voluntarily receive
the risky vaccine.
But before physicians and other healthcare professionals begin lining
up to give and receive the smallpox shots, questions about risk need
answers.
"There is a reluctance from people to participate in the program on
both an individual and organizational basis because of liability
coverage issues," says Jeffrey Elting, M.D., medical director for
bioterrorism coordination for the District of Columbia Hospital
Association. "Any business or institution is going to be concerned
about
that."
Studies conducted in the 1960s found that 15 of every 1 million people
vaccinated for smallpox endured potentially deadly complications. One to
two per million died.
The Homeland Security Act signed in November includes broad liability
protections for pharmaceutical companies that make the vaccine and the
providers who administer it. The act allows people who suffer adverse
reactions and can prove negligence to file claims against the
government. It does not explain how compensation would be paid, except
to say there could be no punitive damages awarded.
Because liability coverage does not kick in until Jan. 24, the first
phase of vaccination would not begin before then without congressional
action, says Joe Henderson, bioterrorism chief for the Centers for
Disease Control and Prevention. In the second phase, about 10 million
healthcare workers will be offered the vaccine.
On Dec. 9, state health agencies submitted vaccination plans to the
CDC with lists of those to mass vaccinate. The plans outline
vaccination clinic locations, health department capabilities, and staff
training and communication strategies.
"The good news is that the national plan is the one we've been
planning on for the last four months," Elting says. "But
clarifying the
liability issues would make everyone rest a lot easier."
After talking with lawyers for hospitals in the D.C. region and with
the American Hospital Association, Elting says it is clear that
Congress will have to work with the CDC and HHS to produce a more
robust liability package.
Public health experts at a Dec. 11 conference in Washington agreed
that apprehensions about liability and compensation must be addressed.
"Once we have the first adverse reaction, it will have a chilling
effect on the program," says Jerome Hauer, the top bioterrorism
official
at the Office of Public Health Emergency Preparedness at HHS.
Sen. Bill Frist, M.D., (R-Tenn.) says the threat of liability is
becoming a barrier to the nation's ability to protect the American
people. "The manufacturing base must be protected in a way that is
fair
and equitable for those making, administering and taking the
vaccine,"
he says.
The program for first responders will be voluntary, but workers who
refuse the vaccine are concerned about workplace discrimination, says
Andrew Stern, president of the Service Employees International Union,
which represents 715,000 healthcare workers. Payment for monitoring
those vaccinated is another issue.
"The Administration and Congress have protected the wealth of the
drug
companies who produce the vaccine, but not the health of hospital
workers and the public," Stern says. "President Bush's smallpox
plan
will put thousands of Americans at unnecessary risk." |
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