Program Overview

Pulmonary arterial hypertension (PAH), an incurable disease, is characterized by medial hypertrophy, intimal fibrosis, and in situ thrombi in small muscular pulmonary arteries. PAH was considered a rapidly fatal illness with a median survival of 2.8 years in the 1980s when no evidence-based therapies were available. Since then the treatment of this disease has made tremendous advances, and in the last 10 years the discovery of new medications have positively influenced the prognosis and survival of patients with PAH.

This self-study activity is based on 4 articles that review ethical considerations in the treatment of pulmonary hypertension (PH).

This activity is jointly sponsored by the University of Michigan Medical School and the Pulmonary Hypertension Association.

Target Audience

This self-study activity is appropriate for cardiologists, pulmonologists, rheumatologists, and other physicians who treat patients with PH.

Learning Objectives

Upon completion of this activity, participants will be able to:

1. Recognize the concepts of therapeutic misconception and clinical equipoise in association with treating patients with PAH
2. Discuss the ethical imperative to provide optimal care to patients and apply those principles to guide collaboration among caregivers that promotes the best possible outcome in the most patients
3. Define challenges in conducting ethical research around the world, including ethical consensus regarding informed consent and benefit sharing, and resolve those in your practice
4. Describe the fundamental mechanisms underlying collaboration with the pharmaceutical industry and regulatory agencies in clinical drug development for the treatment of PAH

Self-Assessment Examination

1. View the entire articles.
2. Complete the online posttest and evaluation.
3. Complete the electronic credit request and activity evaluation. An electronic certificate of participation will be provided immediately.
4. Print the certificate of participation for your personal records.

Faculty

Chair

Harrison W. Farber, MD
Professor of Medicine
Director, Pulmonary Hypertension Center
Boston University/Boston Medical Center
Boston, Massachusetts

Contributing Authors

George J. Annas, JD, MPH
Chair, Health Law, Bioethics and Human Rights
Boston University School of Public Health
Boston, Massachusetts

David B. Badesch, MD
Professor of Medicine
Divisions of Pulmonary Sciences and Critical Care Medicine, and Cardiology
Clinical Director, Pulmonary Hypertension Center
University of Colorado Denver
Aurora, Colorado

Robyn J. Barst, MD
Professor Emerita, Columbia University
Scarsdale, New York

Todd Bull, MD
Associate Professor of Medicine
Divisions of Pulmonary Sciences and Critical Care Medicine
Pulmonary Hypertension Center
University of Colorado Denver
Aurora, Colorado

Marilyn E. Coors, PhD
Associate Professor
Center for Bioethics and Humanities
University of Colorado Denver
Aurora, Colorado

Michael A. Grodin, MD
Professor, Health Law, Bioethics and Human Rights
Boston University School of Public Health
Boston, Massachusetts

Alison Lakin, RN, LLB, LLM, PhD
Director, Colorado Multiple Institutional Review Board
University of Colorado Denver
Aurora, Colorado

Deborah H. McCollister, RN
Senior Professional Research Assistant
Pulmonary Hypertension Center
University of Colorado Denver
Aurora, Colorado

Michael D. McGoon, MD
Consultant in Cardiovascular Diseases
Professor of Medicine
Division of Cardiovascular Diseases
Mayo Clinic
Rochester, Minnesota

Agenda

The Structure of Pulmonary Hypertension Health Care Delivery: Translating Ethical Considerations into Practice
Michael D. McGoon, MD

A World of Research Subjects: Informed Consent and Benefit Sharing
George J. Annas, JD, MPH, and Michael A. Grodin, MD

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies
Robyn J. Barst, MD

The Potential for Therapeutic Misconception in Pulmonary Arterial Hypertension Clinical Trials: A Case-Based Discussion
David B. Badesch, MD; Marilyn E. Coors, PhD; Deborah H. McCollister, RN; Todd Bull, MD; and Alison Lakin, RN, LLB, LLM, PhD

CME Accreditation and Credit Designation

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the University of Michigan Medical School and the Pulmonary Hypertension Association. The University of Michigan is accredited by the ACCME to provide continuing medical education to physicians.

The University of Michigan Medical School designates this activity for a maximum of 2.0 AMA PRA Category 1 Credits.™ Physicians should claim credit commensurate with the extent of their participation in the activity.

Completion of this activity involves reading the journal and completing the self-assessment examination and evaluation form, which may take up to 2 hours. Credits for this self-study program are available from March 28, 2011 through March 27, 2012. There is no fee for this program.

Oversight and Accreditation

Tana O'Lone, Associate Administrator, Department of Medical Education, University of Michigan Medical School

Disclosures

The Accreditation Council for Continuing Medical Education and the Association of American Colleges have standards and guidelines to ensure that individuals participating in CME activities are aware of relationships between authors and commercial companies that could potentially affect the information presented. To be disclosed to participants are all personal financial relationships with a commercial interest whose products are relevant to the content of this CME activity. The University of Michigan Medical School follows these national policies to ensure balance, independence, objectivity, and scientific rigor in all its CME activities. Each author was asked to complete a disclosure information form for this activity. Disclosures are reported below:

David B. Badesch, MD, has received honoraria from Actelion/CoTherix, Gilead/Myogen, Encysive, Pfizer, Mondo-Biotech/Mondogen, Biogen IDEC, United Therapeutics/Lung Rx, Glaxo SmithKline, Lilly/ICOS, Bayer, Ikaria, and Arena. He has received grant support for clinical studies from GlaxoSmithKline, Actelion/CoTherix, Gilead/ Myogen, Pfizer/Encysive, United Therapeutics/ Lung Rx, Lilly/ICOS, Bayer, Novartis, the NHLBI/NIH, and the NIAID/NIH.

Robyn J. Barst, MD, is a consultant to Actelion, Gilead, Eli Lilly, Pfizer, Novartis, and ekanii.

Todd Bull, MD, has received honoraria from Lung Rx and has consulted for Actelion. He has received grant support from the AHA, ATS, Scleroderma Foundation, and the NIH/NHLBI.

Deb H. McCollister, RN, BSN, has received honoraria from Actelion, Gilead, and Ikaria.

Michael D. McGoon, MD, has received honoraria from Actelion, Gilead, LungRx, and GSK.

Michael Grodin, MD, George Annas, JD, MPH, Marilyn Coors, PhD, Alison Lakin, RN, LLB, LLM, PhD, have no relevant personal financial relationships to disclose.

Harrison W. Farber, MD, has received honoraria, served as an advisor and consultant to Actelion, Gilead, United Therapeutics, and Bayer.

CME Reviewer

Kevin Chan, MD
Associate Professor of Medicine
Division of Pulmonary and Critical Care Medicine
University of Michigan Health Systems, Ann Arbor, Michigan

Kevin Chan, MD, has received grant/research support from Alnylam Pharmaceuticals and Gilead.

 

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