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.

      1. 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?
      2. Should the researcher’s refusal to mention possible additional risks be treated as a case of withholding data?
      3. What should the researcher and her postdoc do in light of the evidence that the drug might have serious cardiovascular side effects?

Source: Shamoo, A., & Resnik, D.  (2003). Responsible Conduct of Research. New York: Oxford University Press.