Wednesday, June 10, 2009

Opinion Leaders Discuss Whether Comparative Effectiveness Research Should Include the Costs of Treatments

In the 6/4/09 post on this blog I mentioned the newly created Federal Coordinating Council for Comparative Effectiveness. The coordinating council held a "listening session" in Washington, DC, today. In a listening session, officials of various organizations are invited to make 3 minute presentations to the council, and council members can follow-up with questions posed to the presenters. The listening session is available to view at the following site:

The session is fairly interesting, in that it is a broad cross-section of opinion in the medical community. Most of the presenters are representatives of large organizations, and many are from medical schools. I particularly recommend finding the presentation by Mark Roberts, MD (about half-way through the recording). You can recognize him on the video, because I think he was the only presenter with a beard. Dr. Roberts is Professor of Medicine at the University of Pittsburgh and President of the Society for Medical Decision Making (a scientific society with few ties to industry).

By way of background, the basic premise of comparative effectiveness is that alternative treatments can be compared by examining two categories of outcomes:

Effectiveness: the amount of improvement in a disease among people who use a particular treatment. This can be measured by estimates of health status (severity of symptoms or ability to perform normal activities) and/or by reduction or delay of serious events (such as length of time before death for such diseases as cancers).

Harms: the rate of unexpected events caused by a treatment, such as allergic reactions 9for drugs), new infections (for surgical procedures), or events that do not normally occur (such as bleeding).

In this approach, the cost of a treatment is not considered. A treatment would be preferred over its competitor if its effectiveness were better and its harms were less frequent. However, sometimes, it is not so simple. What if both effectiveness and harms were higher for drug A than for drug B? It is difficult to say whether either drug A or drug B would be preferred. Dr. Roberts made the argument that it is very helpful to look at costs and that this makes a lot of sense when differences in effectiveness and harms between two comparison treatments are small. This approach is known as cost effectiveness studies, and there is a well established scientific method for performing such analyses.

Nevertheless, the use of cost in comparative effectiveness studies has been a lightening rod for controversy. One of the other presenters in today's listening session was James Fasules, a pediatric cardiologist and Senior Vice President of the American College of Cardiology. Dr. Fasules argued that cost considerations would bias comparative effectiveness research and should not be included in the discussion. For yet another point of view, Consumers Union, the giant consumer advocacy organization, has sought to get involved in the debate. See their position paper that argues that comparative effectiveness can reduce the costs of health care (an argument used for including the comparative effectiveness initiative in last winter's federal economic stimulus package).

Getting back to today's listening session, I recommend that you also view the presentation by Dr. Harry Selker, which is about 3/4 through the video (in the third group of presenters). Dr. Selker is a Professor of Medicine at Tufts School of Medicine in Boston. He spoke as a representative of the Society of General Internal Medicine. Dr. Selker made some very good points about governance of federal funding for comparative effectiveness research.

Here is the complete list of speakers. Since each spoke only 3 minutes, it is failry easy to navigate through the video.

Panel 1
Larry Cohen
Executive Director
Prevention Institute

Diane Dorman
Vice President
National Organization for Rare Disorders

James Fasules
Senior Vice President
American College of Cardiology

Frederick Grover
Chair, Council on Quality, Research, and Patient Safety
The Society of Thoracic Surgeons

David Juba
Senior Research Analyst
Fundamental Clinical Consulting, LLC

Joseph Kanter
Joseph H. Kanter Family Foundation & The Health Legacy Partnership

Beth Kosiak
Associate Executive Director
American Urological Association

Diana Zuckerman
National Research Center for Women & Families

Panel 2
Ted Buckley
Director of Economic Policy
Biotechnology Industry Organization

John Cuddeback
Chief Medical Informatics Officer
Anceta - AMGA's Collaborative Data Warehouse

Bill Fox
Executive Director
The National Center for Patient Interactive Research

Martyn Howgill
Executive Director
Institute for Health Technology Studies

Polly Pittman
Executive Vice President

Mark Roberts
President and Professor of Medicine
Society for Medical Decision Making

Patricia Salber
Chief Medical Officer and Senior Vice President
Universal American Corporation

Deneen Vojta
Senior Vice President
UnitedHealth Group

Panel 3
Brendan Carr
Assistant Professor
American College of Emergency Physicians & Society for Academic Emergency Medicine

Matthew Hoffman
Director of Ob/GynResearch
The Eunice Kennedy Shriver NICHD Maternal Fetal Units Network

Jeffrey Lerner
President and Chief
ECRI Institute

Mark Pilley
Medical Director
RS Medical

Harry Selker
Dean, Clinical and Translational Science Institute, Tufts University, Chair Society of General Internal Medicine Health Policy Committee on Research, Society of General Internal Medicine

Eduardo Siguel

Ronald Stewart
Board Chairman
National Trauma Institute

Grace-Marie Turner
Galen Institute

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