October 1996
WASHINGTON, D.C. — The failure of the Centers for Disease Control and Prevention (CDC) to properly notify parents of the use of an experimental measles vaccine in a study at Kaiser Permanente in 1990, highlighted for many the need for more effective and timely risk communication.
Although no adverse events have been reported because of immunization with the vaccine in the United States, the outcry over the lack of informed consent resonated loudly within the public health arena.
"The goal of traditional health risk communication has been to promote behavioral change," said Geoffrey Evans, MD, chief medical officer for the National Vaccine Injury Compensation Program. But the definition of risk communication has evolved over the past decade where it is increasingly seen as "an interactive process of exchange of information and opinion among individuals, groups and institutions, with a discussion about risk types and levels and about methods for managing risks."
That definition, which is contained in a 1989 National Research Council report entitled, "Improving Risk Communication," goes on to state that risk communication is successful "only to the extent it first, improves or increases the base of accurate information that decision makers use, be they government officials, industry managers or individual citizens, and second, satisfies those involved that they are adequately informed within the limits of available knowledge."
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All vaccines carry with them a risk of injury, but the risk is extremely low. By law, all health officials must inform parents of the risks of vaccines. In the incident at Kaiser Permanente, the parents were aware they were participating in a study, but were not informed that the measles vaccine their children were given (the Edmonston-Zagreb vaccine) had not been licensed for use in the United States, although it had been used successfully throughout much of Europe. Later research, however, revealed a small number of deaths in Haiti among young girls who received the vaccine there. This disclosure eventually let to a demand from parents and community organizations for an explanation and apology from the CDC.
Evans' remarks concerned results of an Institute of Medicine (IOM) workshop held in May on vaccine risk communication. This was the fourth in a series of workshops by the IOM's Vaccine Safety Forum, established in 1995 to examine critical issues relevant to the safety of vaccines used in the U.S. and to discuss methods for improving the safety of vaccines and vaccination programs. Membership in the forum includes representatives from parent or consumer groups, vaccine manufacturers, federal agencies responsible for regulating vaccines, and academic medicine. In reviewing key issues that emerged from the workshop, Evans pointed to some important themes.
First, "trust is a key component of risk communication at every level," Evans said. Incidents such as the EZ measles vaccine study create "a polarization of government and the public." This mistrust is unfortunate, "because our goals are the same — the health and safety of children," he said. Add to a growing level of public mistrust the immediate and sometimes inaccurate dissemination of information to the public after any catastrophic event, and it becomes clear how easily miscommunication and the resulting community outrage can occur.
Several other key elements of improved risk communication were outlined at the NVAC meeting:
For vaccines and immunizations specifically, other key points of risk communication include:
Part of the problem with communicating risk is assessing the data and presenting it in an easily understood way. The vaccine information statements (VISs) that providers are required to give to parents are not intended to substitute for provider knowledge or provider/patient interaction.
Criticisms of the current parent handouts included charges that the reading level of many of the handouts was too high (8th grade); they were too long; and the format too complicated. While the Vaccine Information Statements have been considerably shortened and simplified from the much criticized Vaccine Information Pamphlets (VIPs) published in 1991, in the future NVAC will likely review statement prototypes, including a hierarchical information system with varying levels of complexity.
Improving risk communication is an ongoing task, and NVAC considers rebuilding and maintaining the public trust to be of paramount importance in that effort.
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