January 16, 2003 -- Inst of Medicine panel says smallpox vaccination program unadvisable


New York Times, January 16, 2003

Medical Panel Has Doubts About Plan for Smallpox

By DENISE GRADY

The government's plan for smallpox vaccinations is too rushed and
lacks adequate safeguards, according to a draft report by a panel of
independent medical experts convened to advise federal health
officials.

The 15-member panel, mostly medical school professors, was formed by
the Institute of Medicine at the request of the Centers for Disease
Control and Prevention, which sought advice on putting the program
into effect. The panel met Dec. 18-20.

A confidential draft of its report was obtained by The New York Times.
A final, revised version is expected to be sent to the disease centers
and made public next week, a panel member said.

The panel member added: "I think it's saying the decision to vaccinate
was essentially a political one, and there are a lot of scientific
reservations about it. We were not asked to talk about the policy, but
we're saying there are a lot of reservations and safeguards that need
to be put in place."

Dr. Julie L. Gerberding, director of the disease centers, said she had
not seen the report. But, she said: "We have enormous respect for the
I.O.M. The credibility of their input is always taken very seriously
by C.D.C., and we look forward to seeing the final report. That's why
we wanted to take this issue to the I.O.M."

The vaccination program, announced by President Bush on Dec. 13, calls
for up to 500,000 health workers to be vaccinated in the coming weeks.
The second phase is to include 10 million more people: additional
health workers, as well as firefighters, police and emergency medical
personnel.

Concerns about the program center on risks from the vaccine, which has
more dangerous side effects than other vaccines, and caused one or two
deaths per million vaccinations when it was in routine use.

The panel urged that there be enough time allowed between the two
phases to evaluate the first phase and apply any lessons learned.

But Dr. Gerberding said the disease centers and the states would
monitor safety continuously and make needed changes as they went
along.

She said she expected each jurisdiction to operate at its own pace,
but, she added, the guiding principle would be, "the fastest we can do
it with the greatest amount of safety."

The panel also recommended that the disease centers identify specific
criteria, like adverse effects from the vaccine, that would lead it to
reconsider its guidelines for who should be vaccinated and how
potential recipients should be screened.

Dr. Gerberding said she needed to see the full report to evaluate that
advice.

In another recommendation, the panel said the disease centers should
designate one "voice" for the vaccination program, someone with a
strong scientific background, and not a politician.

When asked to comment, Dr. Gerberding laughed and said: "I'd really
love to answer that question but I can't comment on that. In reality,
there are a lot of people who are going to be involved in providing
messages about events related to terrorism."

The panel member said that when the group recommended against
politicians, "what we had in mind was the debacle around anthrax and
how there was no designated scientific spokesperson and how the public
was confused by various sources of information until they finally put
Dr. Fauci forward, who is a credible source." Dr. Anthony S. Fauci is
director the National Institute of Allergy and Infectious Diseases.

Another issue that concerned the panel was who will cover lost wages
and medical expenses for people who have adverse effects from the
vaccine. The federal government will not provide coverage, and, the
panel noted, it is not clear whether state worker's compensation laws
will help. It urged the disease centers and state health departments
to clarify the issue and to make sure that consent forms describe what
compensation is available.

Dr. Gerberding said that although the disease centers provided some
guidance, both compensation and consent forms would ultimately be
decided by individual states.

The Institute of Medicine panel said the safety board in charge of
monitoring the vaccination program should be independent of the
government in order to maintain public trust. But current plans call
for the safety board to be connected to a disease centers advisory
group, and the institute's panel urged the centers to reconsider that
arrangement.

In response, Dr. Gerberding said, "We've had input from a variety of
sources on that and will take whatever input we get from I.O.M. very
seriously."