Asymmetry in the Ability to Communicate CER Findings Conference

  • February 9, 2012 - 9:00am
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Every patient and provider wants to make the best possible decision about health care treatments, which makes it very important to have adequate information about the effectiveness and safety of those interventions.

With billions of dollars being invested in comparative effectiveness research (CER), it is likely that the public will have increased access to health information in coming years. Yet as more and more information is communicated to patients, practitioners and payers, current regulatory policy may create asymmetries, or inequalities, in the ability of different stakeholders to convey information.

Overview

On February 9, 2012 in Washington, DC, National Pharmaceutical Council hosted a conference to start this conversation by bringing together leading experts to discuss key issues, such as

  • An ethical framework for considering asymmetry in CER communications
  • Patient and other stakeholder information needs
  • CER, the Food and Drug Administration and the First Amendment challenge
  • Ensuring access to information

Expand for Agenda

To view speaker presentations (PDF format), please click on the speaker's name. Presentations are not available for all speakers.

8:30 a.m. Contential Breakfast & Registration Open

9:30 a.m. Welcome from the Sponsors and Opening Comments

  • Dan Leonard, President, National Pharmaceutical Council (NPC)
  • Marcus D. Wilson, PharmD, President, HealthCore

9:45 a.m. What’s the Problem? Framing the Discussion of Asymmetry in Communicating CER Findings

  • Robert (Bobby) W. Dubois, MD, PhD, Chief Science Officer, NPC

10:15 a.m. CER, FDA and the First Amendment Challenge

  • Moderator: Robert (Bobby) W. Dubois, MD, PhD, Chief Science Officer, NPC
  • Tevi Troy, PhD, Senior Fellow, Hudson Institute; Former Deputy Secretary, U.S. Department of Health and Human Services
  • Gerald F. Masoudi, Partner, Covington & Burling LLP

11:15 a.m. An Ethical Framework for Considering Asymmetry in CER Communications

  • Arthur L. Caplan, PhD, Emmanuel and Robert Hart Director of the Center for Bioethics; Sidney D. Caplan Professor of Bioethics, University of Pennsylvania

12:00 p.m.  Networking Lunch

1:15 p.m. Communicating CER Findings for Health Care Decision Making: Who Decides? Who Can Speak?

  • Moderator: Robert (Bobby) W. Dubois, MD, PhD, Chief Science Officer, NPC
  • Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute; Senior Advisor, Avalere
  • Aaron S. Kesselheim, MD, JD, MPH, Assistant Professor of Medicine, Harvard Medical School; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital

2:15 p.m. Stakeholder Needs, Challenges and Opportunities in CER Communications

  • Moderator: Susan Dentzer, Editor-in-Chief, Health Affairs/Project HOPE
  • Provider: Joshua D. Lenchus, DO, RPh, FACP, FHM, Associate Director, University of Miami - Jackson Memorial Hospital Center for Patient Safety; Associate Professor of Medicine, University of Miami Miller School of Medicine
  • Payer: Marcus D. Wilson, PharmD, President, HealthCore
  • Patient: Stephen Hume, PsyD, Alzheimer’s Patient Representative
  • Patient Caregiver: Candace Darcy, Alzheimer’s Patient Care Partner
  • Industry: Steven J. Romano, MD, Senior Vice President, Head, Medicines Development Group, Primary Care Business, Pfizer Inc

3:05 p.m. Ensuring Access to Information for Health Care Decision Making: What is Reasonable and How Can It Be Achieved?

  • Moderator: Susan Dentzer, Editor-in-Chief, Health Affairs/Project HOPE
  • Marcus D. Wilson, PharmD
  • Stephen Hume, PsyD
  • Tevi Troy, PhD
  • Candace Darcy
  • Joshua D. Lenchus, DO, RPh, FACP, FHM
  • Arthur L. Caplan, PhD
  • Steven J. Romano, MD

4:00 p.m. Keynote Address – View from the FDA

  • Robert J. Temple, MD, Deputy Center Director for Clinical Science, Center for Drug Evaluation and Research, and Acting Deputy Director, Office of Drug Evaluation I, U.S. Food and Drug Administration

4:30 p.m. Summary and Adjournment

  • Robert (Bobby) W. Dubois, MD, PhD, Chief Science Officer, NPC