On Thursday, October 11, Health Affairs will hold a briefing to unveil its October 2012 issue, “Current Challenges In Comparative Effectiveness Research.” The volume examines how findings from comparative effectiveness research will be communicated, particularly if they pertain to prescription drugs and if the findings could be useful for promotional purposes yet fall short of the standard of “substantial evidence” required by the Food and Drug Administration (FDA) under federal law.

The cluster of articles includes a hypothetical case study of comparative effectiveness research involving a fictional migraine drug and a symposium of analyses and responses follows from various stakeholders. The issue received funding support from the National Pharmaceutical Council.

Please join us for a briefing at the Washington Marriott at Metro Center on Thursday, October 11, 8:30 a.m.12:30 p.m., as we unveil the issue.


Thursday, October 11, 2012

8:30 a.m. – 12:30 p.m.


Washington Marriott at Metro Center

775 12th Street, NW (Metro Center)

Washington, DC, 20001

Register Now!

You can also follow the briefing on the Twitter channel @HA_Events, and you can join in the conversation using the hashtag #HA_CER.

Panels will examine:

  • Legal Issues On Promotion And Communication Of Comparative Effectiveness Research
  • Patients’ Concerns And Patient Centeredness
  • The Use Of Research By Payers And Clinicians
  • Moving Comparative Effectiveness Research Forward

Among the issue authors and other speakers at the briefing will be:

  • Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council, on Among Other Flaws, Hypothetical Migraine Study Lacks Independent Evaluation And Patient Engagement
  • Arthur Caplan, New York University, on Enhancing Patient Autonomy Through Peer Review To Replace The FDA’s Rigorous Approval Process (invited)
  • Robert DuBois, Chief Science Officer, National Pharmaceutical Council – Respondent
  • Michael Fischer, Assistant Professor of Medicine, Harvard Medical School; Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital on Academic Detailing Can Play A Key Role In Assessing And Implementing Comparative Effectiveness Research Findings
  • Rachael Fleurence, Scientist, Patient-Centered Outcomes Research Institute, on Reviewing Hypothetical Migraine Studies Using Funding Criteria From The Patient-Centered Outcomes Research Institute
  • Aaron Kesselheim, Research Associate, Department of Health Policy and Management, Harvard School of Public Health, on The Food And Drug Administration Has The Legal Basis To Restrict Promotion Of Flawed Comparative Effectiveness Research
  • Daniel Leonard, President, National Pharmaceutical Council
  • Eleanor M. Perfetto, Senior Director, Evidence Based Strategies, Pfizer Inc., on Communication About Results Of Comparative Effectiveness Studies: A Pharmaceutical Industry View
  • Harold C. Sox, Editor Emeritus, Annals of Internal Medicine, on The Patient-Centered Outcomes Research Institute Should Focus On High-Impact Problems That Can Be Solved Quickly
  • Justin W. Timbie, Associate Policy Researcher, RAND, on Five Reasons That Many Comparative Effectiveness Studies Fail To Change Patient Care And Clinical Practice
  • Tevi Troy, Senior Fellow, Hudson Institute – Respondent (invited)