A dose of confidence

December 21, 2004|By Daniel Salmon Neal Halsey and Lawrence Moulton

LEADING 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with approving the safety and efficacy of drugs but then must also decide after its approval if a drug should be withdrawn.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.

Daniel 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. Neal Halsey is the director, and Lawrence Moulton is the co-director.

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