The FDA Amendments Act (FDAAA) of 2007 significantly extended the FDA’s regulatory authority regarding postmarket drug safety. Among other provisions, the act requires that drug labeling changes based on new safety information be done in accordance with strict timelines. New programs, including the Sentinel Initiative launched in May 2008, are part of the FDAAA-mandated thrust to develop a nationwide system for monitoring postmarket medical product safety. “The current system of voluntary reporting, through AERS, isn’t adequate to the task that we as a society face today,” stated Dr. Seligman. During postpresentation discussion, Dr. Seligman conceded that the FDA’s efforts to increase transparency and provide more safety information often carry unintended consequences.
Getting the Gist of Risks
With the increasing complexity of treatment options and wide availability of drug safety information, physicians must continue to play a key role in helping patients weigh risks and benefits of treatment, asserted second presenter Valerie Reyna, PhD, professor of human development and psychology at Cornell University in Ithaca, N.Y., and director of the Center for Behavioral Economics and Decision Research. This can be a difficult task, she said, because most people—including physicians—are uncomfortable when having to make trade-offs between risks and benefits of a given treatment. One reason for this is, because they occur in noncommensurate dimensions, benefits (relief from pain) cannot be directly compared with risks (possibility of increased infection). It can be helpful, therefore, to understand what cognitive research has revealed about risk perception, which consists of four main components:
- Knowledge: This includes not just background information but life experiences that inform the comprehension of that knowledge;
- Representation: The gist or essence of the information, and how is that understood, or represented;
- Retrieval: How one accesses information in order to make a decision; and
- Processing: Combining one’s representation of information with what is retrieved to generate a decision.
Each of these components can present difficulties, and result in risk perception errors. For instance, Dr. Reyna said, verbatim representation of risk, often a featured component of informed consent, can present problems for clinical trial enrollees. Investigators have been cautioned to test potential participants’ comprehension of risks by asking them to repeat information verbatim. But, she noted, if patients are not given the gist of the information—that is, the interpretation of its essence—this can result in a misperception of risk, as Dr. Reyna noted in her paper1 commenting on a 2001 study by Lloyd et al that tested understanding of risk in those scheduled for carotid endarterectomy.2 In that study, patients often correctly recalled the gist of risk (22% risk of dying from a stroke if they didn’t have the surgery), but many got the verbatim estimates wrong (some thought they had a 100% chance rather than a 22% chance of dying without the surgery).
