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Understanding the Benefits and Risks of Pharmaceuticals Workshop Summary (2007) / Chapter Skim
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3 The Challenge of Communication
Pages 32-38

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From page 32...
... make it difficult for physicians to effectively communicate about risks and benefits with their patients. Physicians tend to underestimate the amount of information that patients want, control discussions and discourage patient involvement, overestimate how much patients know, overestimate the efficacy with which they accomplish important communication tasks (how well they have communicated information to their patients)
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From page 33...
... Visual aids can range from bar charts and line graphs to risk ladders and stick figures. The advantages of visual displays are that they can summarize lots of data; help the patient see patterns that would otherwise go undetected; help the patient perform some mathematical operations, such as comparisons,
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From page 34...
... Some ads assert efficacy rather than provide data (e.g., "works for me") ; others contain data about popularity but, again, nothing about efficacy (e.g., "more than one million people have begun using Rezulin to help manage diabetes")
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From page 35...
... Questions were raised about the discrepancy between Dr. Woloshin's encouraging results with respect to patients' abilities to analyze, digest, and make fairly sophisticated decisions about benefit–risk information and Dr.
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From page 36...
... 5. FDA drug approval documents, including medical, chemical, statistical, and other reviews of drug company applications, are freely available on the Internet;3 however the large quantity of critical data, lack of structure, and difficult reading make accessing the information overwhelming.
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From page 37...
... She described a 1994 crisis situation, when an FDA market basket survey detected an illegal pesticide, chloropyrifos-ethyl, in oat cereal and discussed how the EPA and FDA cooperated on risk assessment and communication strategies and successfully resolved the situation.
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From page 38...
... It was noted that this is an excellent demonstration of the fact that very reasonable people have diametrically opposed views about what the FDA should do on any given matter. A comment was made about how much of the workshop discussion focused on academics, industry and consumers, but that the entire FDA regulation process relies on the prescribing physician as a critical "learned intermediary." The complete absence of participation by such groups in the FDA regulatory process is striking.
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Key Terms

  • risk information
  • risk communication
  • efficacy data
  • visual aids
  • schwartz argued

  • drug labels
  • numerical risk
  • conveying risk
  • risk ladders
  • drug approval

  • drug company
  • fda drug
  • approval documents
  • tabular format
  • limited time

  • patient involvement
  • communication lead
  • simple tabular
  • dartmouth university
  • brief summaries

  • contain data
  • prototype prescription
  • fda requires
  • access drug
  • fda approval

  • medical risk
  • risk measured
  • risk data
  • data tend
  • fda market


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