"How likely is such independent oversight for vaccines? ...
The CDC... convened a blue-ribbon panel to review the
vaccine safety program.... But instead of an open debate
with the medical and public health communities, the CDC
held a closed-door meeting. Neither the transcript of the
meeting nor the panel's report has been made public."

Salmon, Halsey & Moulton: Focus on vaccine safety

By Daniel Salmon, Neal Halsey & Lawrence Moulton
http://www.DODGEGLOBE.COM/stories/122804/opinions_122804013.shtml

Reading medical journal editors and lawmakers have
rightfully focused a spotlight on how well the Food and Drug
Administration monitors the safety of drugs after they are
approved.

But still lost in the shadows is how well we monitor the
safety of one of the largest class of drugs routinely
administered to people in the United States - vaccines.

In the debate over the safety of drugs such as Vioxx and
Celebrex, critics of the current system have pointed to the
inherent conflict within the FDA, which is charged with
approving the safety and efficacy of drugs but then must
also decide after its approval if a drug should be
withdrawn.

An even more subtle and insidious conflict exists with
respect to vaccines. The responsibility for post-license
safety evaluation of vaccines is shared between the FDA and
the National Immunization Program (NIP) of the Centers for
Disease Control and Prevention.

The NIP conducts most post-licensure epidemiological
investigations of vaccine safety. However, it also purchases
more than half of all pediatric vaccines administered in the
United States and supports state and local immunization
programs through staffing and funding. This dual role of the
NIP to promote immunizations and conduct safety evaluations
creates the potential for real and perceived conflicts of
interest.

The credibility of post-licensure vaccine investigations and
vaccine promotion efforts would be enhanced by moving the
safety assessment activities out of the NIP and establishing
an independent oversight board such as a National Vaccine
Safety Board.

How likely is such independent oversight for vaccines? In a
commentary published in the American Journal of Public
Health in June, we made such a proposal. Both the CDC and
FDA responded to our published commentary and recognized the
perceived conflict of interest. The CDC then convened a
blue-ribbon panel to review the vaccine safety program and
where it should be located. But instead of an open debate
with the medical and public health communities, the CDC held
a closed-door meeting. Neither the transcript of the meeting
nor the panel's report has been made public. This is hardly
an auspicious beginning to resolve this issue and build
confidence in vaccine safety.

The FDA is responding to the perceived conflict of interest
in drug safety by sponsoring an Institute of Medicine review
of drug safety issues. Vaccine safety should be included in
this review.

Vaccines are one of our greatest achievements in medicine
and public health, preventing untold suffering and death.
The success of vaccines has resulted in many parents being
unfamiliar with the diseases prevented, and their focus has
shifted from the risks of disease to the risks of vaccines.

Our recent studies reveal that the rates of parents refusing
vaccines have been increasing; vaccine safety concerns and
distrust in government are important reasons why some
parents do not vaccinate their children. We need to maintain
high levels of vaccine coverage to prevent outbreaks of
preventable diseases. Greater independence of vaccine safety
assessment is needed to preserve public confidence in
vaccines and our government.

###

Salmon is the associate director for policy and behavioral
research at the Institute for Vaccine Safety at the Johns
Hopkins University's. Bloomberg School of Public Health.
Halsey is the director, and Moulton is the co-director.

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