Title: Reporting Adverse Effects
Author: Anji Wall
Description: A researcher finds out that a drug she is promoting at a pharmacological conference may have serious adverse effects.
Keyword(s): Conflict of Interest, Mentor-Trainee Relationship, Withholding Data
Based On: (Shamoo & Resnik, 2003, p. 157)
Case: A researcher at a prestigious university has a postdoctoral fellow who has been studying one specific aspect of a new drug that has just been approved by the FDA. The company that has developed the drug pays the researcher $15,000 per year in consulting fees. The company sponsors a conference in San Francisco to bring together the leading researchers working on this drug. This conference is an all-expense paid trip for the speakers and physicians that attend, with the speakers receiving a $5,000 honorarium. The researcher plans to attend and teach at the conference, but is informed by his post-doc that she has new data suggesting that the drug may have serious cardiovascular side effects. The researcher thanks the post-doc for her work, but only plans to report on published findings and will omit the new information about the drug’s dangers.
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- Does the researcher have a conflict of interest? If so, what is the nature of the conflict? Does the conflict raise any concerns? If not, why not?
- Should the researcher’s refusal to mention possible additional risks be treated as a case of withholding data?
- What should the researcher and her postdoc do in light of the evidence that the drug might have serious cardiovascular side effects?
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Source: Shamoo, A., & Resnik, D. (2003). Responsible Conduct of Research. New York: Oxford University Press.