Understanding the Benefits and Risks of Pharmaceuticals Workshop Summary (2007) / Chapter Skim
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4 The Importance of Context in Healthcare Decision Making
4 The Importance of Context in Healthcare Decision Making
Pages 39-51
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From page 39... ...
In order to determine how people perceive and assess benefit–risk relationships, he listed some assertions that we need to consider: there are different types of decisions about benefit and risk of pharmaceuticals; risk is not a well-defined concept, and cavalier use of the word may contribute to the challenges associ 1This section is based on the presentations of Paul Slovic, Decision Research; Peter Ubel, University of Michigan; Sheila Jasanoff, Harvard University; Hal Sox, Annals of Internal Medicine; Carl Spetzler, Strategic Decisions Group; Kevin Schulman, Duke University; and Peter Barton Hutt, Covington & Burling LLP.
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Patients rely on their own knowledge, feelings, and memories when constructing preferences, and the way that information is presented or framed can readily alter their decisions. There are no neutral frames, so this poses a tremendous challenge to communicating benefit–risk information.
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Slovic's thesis: a range of contextual factors affect people's perceptions of risk versus benefit and guide decision making.
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Public risk perceptions are influenced by systematic cognitive biases, (2) These cognitive biases produce erroneous assessments of probability, and (3)
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; express uncertainty and ignorance; diversify communication strategies; adopt an experimental approach to approval, communication, and learning (rather than a marketing approach) , including a postapproval means of providing feedback and implementing corrections; and improve our sense of responsibility, given that we do not live in a zero-risk world and that people will inevitably get hurt.
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Dr. Sox then explained how a "decision tree" is used to make rational decisions based on the expected value decision-making model.
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• Instantaneous consumer responses gathered in an experiment are not necessarily the same decisions that would be made by that consumer as a patient. Most treatment decisions include family members and other trusted advisers.
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How Patients Make Decisions About Therapy Dr. Schulman presented three case studies representing typical treatment decision-making situations: a 70-year-old healthy female patient
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Schulman explained how, within a prospect theory framework, the model can be used to predict whether a patient is making a treatment decision under a condition of gains (risk aversion; more interest in avoiding risk than gaining benefit; not much toleration for uncertainty around risk) or losses (risk seeking; more interest in benefits than in risks; will tolerate uncertainty around benefits)
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From page 48... ...
There would be full, complete disclosure to physicians and patients, with the FDA retaining power to prevent the marketing of outright poisons and to prohibit the marketing of drugs with no efficacy data or where there is no difference in outcome between the test drug and a placebo. Efficacy data would be presented to the public such that individual patients could decide whether they want to accept the risk in order to gain the possibility -- not probability -- of benefit.
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Mr. Hutt responded by arguing that, under his proposed changes, drug products would still need to go through an FDA approval process, which would include determination of risk and benefit.
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Mr. Hutt argued that while the current system should retain its rigorous evaluation of safety and benefit, it must break out of its "statistical stranglehold." When statistics dominate the entire drug regulatory approval process, he argued, the end result is distorted because it does not account for individual variability.
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" Mr. Hutt responded by emphasizing, again, that approval would require separation in the clinical trial between the active agent and a placebo.
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